CN105640606B

CN105640606B - Medical treatment device for correcting left auricle of heart and relevant system and method

Info

Publication number: CN105640606B
Application number: CN201610091844.0A
Authority: CN
Inventors: S·D·迈尔斯; C·C·戴维斯; D·R·艾德米斯顿; R·J·林德
Original assignee: Coherex Medical Inc
Current assignee: Coherex Medical Inc
Priority date: 2009-06-17
Filing date: 2010-06-17
Publication date: 2018-10-09
Anticipated expiration: 2030-06-17
Also published as: CN102612345B; CA2958337C; CA2958333A1; US8715318B2; JP6026573B2; US10076337B2; JP5698228B2; US20170290595A1; US20180368856A1; US9883864B2; US10582929B2; CA2958337A1; US20140207169A1; EP3449843A1; AU2010262859A1; CN105640606A; US11000289B2; EP3453337A1; US20100324588A1; CA2958338C

Abstract

Provide the devices, systems, and methods of the opening in the bodily tissue for occluding such as left auricle of heart.In one embodiment, a kind of system for occluding the opening in bodily tissue includes：It manipulates；Conduit, the medical treatment device that the conduit is connected to the manipulation and is arranged in the lumen of the conduit.The medical treatment device includes with the anchor system with the joining multiple anchor sections of anchor central part.The medical treatment device further includes with the closer system with the joining multiple closer sections of closer central part.First actuator is configured to make the closer central part independently of and relative to the anchor central part displacement the closer system is deployed to extended mode from retracted mode when the anchor system is maintained at retracted mode.

Description

Medical treatment device for correcting left auricle of heart and relevant system and method

Present patent application is that international filing date is June 17, international application no PCT/US2010/ in 2010 The PCT Patent Application of 039068, entitled " medical treatment device for correcting left auricle of heart and relevant system and method " (national application number：201080035094.6) divisional application.

Cross reference to related applications

The U.S. Provisional Patent Application No.61/218,018 that is submitted this application claims on June 17th, 2009, in January, 2010 The U.S. Provisional Patent Application No.61/294,058 that submits for 11st, the U.S. Provisional Patent Application submitted on April 2nd, 2010 The U.S. Provisional Patent Application No.61/325,230 and May 17 in 2010 that No.61/320,635, on April 16th, 2010 submit The U.S. Provisional Patent Application No.61/345 day submitted, 514 equity, complete disclosure in each of these applications are logical The mode for crossing reference is incorporated herein.

Technical field

The present invention relates to the occlusion or amendment that relate generally to tissue openings or auricle, more particularly relate to occlusion or Ground structure changes device, the system and method for this opening and auricle (including such as left auricle of heart).

Background technology

The main room (atrium) of heart have the auricle being attached in each of which.For example, left auricle of heart is owner Heart feature.The physiological function of this auricle is not fully understood, but they are true during the conventional suction of heart It is implemented as filling memory.Auricle typically from atrium protrusion and covers the exterior section in atrium.Auricle is substantially different each other. For example, an auricle can be structured as conical protrusion, and another auricle can be structured as cavity, sock hole.Auricle Inner surface usually has girder with the fiber of cardiac muscular tissue, its surface is crossed with one or more valves (lob).

When blood is drawn through auricle during normal cardiac function, auricle shows as inertia.In other words, just Auricle does not show to have to being aspirated through significantly affecting for their blood during normal blood function.But in atrium In the case of fibrillation, when atrium enters arrhythmia cordis, blood may collect in the inside of auricle and form thrombus.This Outside, the risk of apoplexy may be led to when it is happened in left auricle of heart, this is because once normal sinus rule is in arrhythmia cordis thing Restore that thrombus may be extracted out to heart and enter brain after part to recycle.

Past, auricle are corrected by operation to reduce the risk caused by atrial fibrillation sometimes.In recent years, Through introducing the device that can be transported to through skin in left auricle of heart.The basic function of these devices is to exclude auricle by implantation material Interior volume, the implantation material form thrombus and then gradually enter heart group with being then able to make the blood safety in auricle In knitting.The process can leave smooth, endothelialization together with the endothelial growth on the surface of device in the position of auricle Surface.Compared with surgical operation, the device that is percutaneously implantable is associated with left auricle of heart less invasive for solving the problems, such as Device.

But it is widely varied due to the arteries and veins mouth size of left auricle of heart and volume, current implantable device generally includes not The structure that this variation can be met constructs inappropriate device so as to cause for many left auricle of hearts.In addition, this implantable dress Setting is restricted substantially can smoothly dispose on their direction.It is advantageous to provide a kind of percutaneous system, sides as a result, Method and/or device, the problem of capable of solving the problems, such as such as variation in implantation material direction, the size of atrium sinistrum and volume, or The all these problems of person, to provide left auricle of heart modified high success rate.It is also contemplated that a kind of device, system and method are provided, It can be easily positioned relative to structure that is being corrected or being blocked for and relocating device, include independently of device other Component or feature location (or repositioning) closer part.

When the illustrating of various embodiments that reading is illustrated below, multiple feature and advantage are for those skilled in the art It will be apparent for member.

Invention content

The embodiment of the present invention is related to occluding the various devices, systems, and methods of the opening in bodily tissue.For example, one In a embodiment, a kind of medical treatment device for correcting the left auricle of heart (" LAA ") of heart is provided.The medical treatment device includes tool There is the closer part of close end and distal portion.Anchor portion is operatively coupled to the closer part.The anchoring Device part includes multiple anchor sections, each has first end and the second end, wherein first and second end is leaned on The distal portion of the nearly closer.

According to another embodiment, a kind of medical treatment device is provided, the medical treatment device includes closer part and anchor Part, wherein the closer part includes the multiple closer sections being connected on main central part, the anchor portion packet Include the multiple anchor sections being connected on the main central part and anchor central part.When the closer part is maintained at portion When affixing one's name in closer state, the anchor central part can be shifted independently of and relative to the main central part, will be described Anchoring section is deployed to spread anchorage device state from retraction anchor state.When the anchor section is in retraction anchoring When in device state, the anchor central part is positioned close to the main central part.

In another embodiment, another medical treatment device of the left auricle of heart for correcting heart is provided.The medical treatment device It include the closer part with close end and distal portion.The close end is attached to central part, and the closer part It is configured to move between closer deployable state and closer non-deployment state.Anchor portion is operably coupled to described Closer part.The anchor portion is configured to move between anchor deployable state and anchor non-deployment state.When When the anchor portion is in the anchor non-deployment state, the distal portion of the closer part is far from described The distal portion of anchor portion is arranged.

Another medical treatment device with closer part and at least one central part is provided, wherein the closer part With multiple closer frame sections.The closer frame section has close end and distal portion, wherein the close end connects It is connected at least one central part.Anchor portion with multiple anchor frame sections can be in contraction state and extension It is moved between state.The anchor frame section respectively including first end and the second end and is located at the first end and institute State the centering portions between the second end.Each in the first end is attached at least one central part and institute Each stated in the second end is coupled together.The second end of the anchor frame section is configured to relative to institute The close end of closer frame section is stated to distal end and proximal movement, between the extended mode and the contraction state Movement.The second end of the anchor frame section is configured to when in the contraction state close to the occlusion The close end of device frame section positions.

In another embodiment, another medical treatment device of the left auricle of heart for correcting heart is provided.The medical treatment device Including the closer part being connected on central part.The closer part is configured to non-in closer deployable state and closer It is moved between deployable state.Anchor portion includes the multiple anchor sections being configured to the tissue permanent engagement in LAA.Institute Each in anchor section is stated with first end and the second end, the first end is attached to the central part.Institute Anchor portion is stated to be configured to transport between anchor deployable state and anchor non-deployment state by the central part It is dynamic.

According to another embodiment, the another medical treatment device for correcting left auricle of heart is provided.The medical treatment device includes connection It is connected to the closer part on central part, the central part defines the hole passed through.Anchor portion include be configured to Multiple anchor sections of tissue permanent engagement in LAA, wherein each in the multiple anchor section can pass through The hole of the central part moves between retracted position and deployed position.

In another embodiment, a kind of medical treatment device is provided, the medical treatment device includes central part and closed with multiple Fill in the closer part of device frame section.The closer frame section includes proximal part and distal portion, the proximal part It is connected to the central part.Anchor portion has multiple anchor frame sections, includes each first end and the second end And the centering portions between the first end and the second end.Each in the first end is attached to institute Central part is stated, the second end is coupled together, and the centering portions can be shifted by the central part.

According to other embodiment, another medical treatment device of the left auricle of heart for correcting heart includes being connected to central part Closer part and include the anchor portions of multiple anchor sections, wherein the central part is defined and is passed through Hole.Each in the multiple anchor section has the first end being connected with the central part.Each frame section The hole for extending partially across the central part other than the first end.

Another embodiment of the medical treatment device for correcting left auricle of heart includes：It is connected to the closer portion on central part The anchor portion for dividing and being operably linked on the closer part.The anchor portion is configured to inside scroll and arrives Retracted position and outside scroll are to deployed position.

In another embodiment, the medical treatment device for correcting left auricle of heart includes：It is connected to the closer portion on central part The anchor portion for dividing and being operably linked on the closer part.The anchor portion is configured to by will be described Anchor portion relative to the closer part at least partly in overturning to move to retracted position.The anchor portion It is also configured to by being overturn outside the anchor portion at least partly relative to the closer part to move to deployment Position.

According to other embodiment, a kind of medical treatment device for correcting the left auricle of heart of heart, and the doctor are provided It includes the closer part being connected on central part to treat device.The closer part can be in non-deployed position and deployed position Between move.Anchor portion is operably coupled to the closer part.The anchor portion includes having engagement structure Multiple anchor sections of part, the engagement member are orientated and are configured to be in tissue bonding station when the anchor portion It is engaged with the tissue of LAA when middle.Described device further includes multiple extensions, and each extension is attached to associated anchor Section and from the position adjacent with the engagement member inwardly and proximally extend.Each extension is also configured to close when described Plug device is pulled proximally when being partially in the deployed position so that the engagement member is transported from the tissue bonding station Move tissue unengaged position.

Another embodiment of present aspect includes the medical treatment device of the left auricle of heart for correcting heart and includes：In being connected to Closer part in center portion and the anchor portion being operably linked on the closer part.The anchor portion Include the multiple engagement members extended from it.The anchor portion can be transported between complete deployable state and non-deployment state It is dynamic.The multiple engagement member is orientated when the anchor portion is in the complete deployable state from the anchor Part proximally extends, and the multiple engagement member is orientated when the anchor portion is in the non-deployment state When from the anchor portion to distal end extend.

According to yet another embodiment, a kind of medical treatment device for correcting the left auricle of heart of heart is provided.The medical treatment device Including：The closer part being connected on central part and the anchor portion being operably linked on the closer part. The anchor portion includes multiple anchor sections, and at least one anchor section includes longitudinal length, width and depth.Institute Longitudinal length is stated along bending part to extend between the first end and the second end of at least one anchor section.Institute Depth is stated along the longitudinal length substantially constant, and the width changes along at least part of the longitudinal length.

According to another embodiment, a kind of medical treatment device for correcting the left auricle of heart of heart is provided.The medical treatment device Including：From the closer part that central part extends and the anchor portion being operably linked on the closer part.Institute It includes multiple anchor sections to state anchor portion, and at least one anchor section includes longitudinal length, width and depth, wherein The longitudinal length extends along bending part between the first end and the second end of at least one anchor section. At least one anchor section has along at least part of the longitudinal length is more than 1:1 depth is higher than width Width is than (aspect ratio).In some embodiments, the depth-width ratio can be between about 1.1:1 and about 5.7:Between 1.

In a further embodiment, a kind of medical treatment device for correcting the left auricle of heart of heart, and the doctor are provided It includes the central part for having outer surface and inner surface to treat device, and the central part defines the hole passed through.Closer part With multiple separate and distinct closer frame sections, wherein the closer frame section is respectively separately and independently attached to The outer surface of the central part.Each closer frame section has the configuration of general plane.Anchor portion includes more A separate and distinct anchor frame section, wherein each in the anchor frame section includes first end and Two ends.The first end of each in the anchor frame section is respectively with the closer frame section to replace The mode of arrangement is separately and independently attached to the outer surface of the central part.It is each in the anchor frame section A the second end is coupled together.Each configuration with general plane in the anchor frame section.

In another embodiment of the present invention, a kind of medical treatment device for correcting the left auricle of heart of heart is provided.It is described Medical treatment is including one or more central parts with outer surface and inner surface, one or more of central parts define across Hole therein.Closer part includes multiple separate and distinct closer sections, wherein the closer section respectively separation and Independently it is attached to one or more of central parts.Each closer frame section has the configuration of general plane.Anchor Part includes multiple separate and distinct anchor frame sections, wherein each in the anchor frame section includes First end and the second end.Each in the first end of the anchor frame section separately and independently couples To one or more of central parts.Each in the second end of the anchor frame section is coupled together. Each configuration with general plane in the anchor frame section.

In a further embodiment, a kind of method of left auricle of heart that correcting heart is provided.The method includes：Using defeated It send the conduit of system that medical treatment device is made to advance through vascular system and enters in the left auricle of heart of heart, wherein the medical treatment device Including：The closer part being connected on central part and the anchor portion being operably linked on the closer part. The closer part is deployed in the anchor portion in LAA and disposed from the transport system and is moved in LAA.Portion of institute Optimum position of the closer part of administration in LAA is identified.In the optimum position for confirming disposed closer part Later, the anchor portion moves between retracted position and deployed position.Tissue in LAA and the anchor portion phase Engagement is by the closer anchoring portions or to be fixed in the optimum position in LAA.

In another embodiment, a kind of medical device delivery system is provided.The system comprises：With closer part With the medical treatment device of anchor portion.Conduit includes extending through tether therein, and the tether is releasably attached to described Medical treatment device.Steerable system is attached to the conduit and is attached to the tether.The steerable system includes can be first The mode switch moved between position and the second position.The mode switch includes one or more keyholes, wherein one Or multiple keyholes are configured to activate described in the medical treatment device when the mode switch is in the first position Anchor portion, and one or more of keyholes are configured to prevent when the mode switch is in the second position Activate the anchor portion of the medical treatment device.

According to another embodiment, a kind of medical device delivery system is provided.The system comprises with closer part With the medical treatment device of anchor portion.Conduit includes extending through closer tether and anchor tether therein, wherein described Closer tether is releasably attached to the closer part, and the anchor tether is releasably attached to the anchoring Device part.Steerable system is attached to the conduit, wherein the steerable system includes：It is connected on the closer tether Closer actuating element, the anchor actuating element being connected on the anchor tether and can be in first position and second The mode switch moved between position.The mode switch is configured to independently make the anchor when in the first position Determine that device part moves between deployed position and retracted position and the closer part is maintained in deployable state.In addition, working as When the mode switch is in the second position, it is configured to prevent the fortune of the anchor portion of the medical treatment device It is dynamic.

According to yet another embodiment, a kind of medical treatment device for correcting the left auricle of heart of heart is provided.The medical treatment device Including：Central part and the closer part being connected on the central part.The central part is configured in closer non-deployment position It sets and is moved between closer deployed position.Anchor portion is operably coupled to the closer part and is configured to solely The movement for standing on the closer part moves and the occlusion between anchor non-deployed position and anchor deployed position Device is partially in the closer deployed position.The medical treatment device is configured to be partially in the occlusion when the closer It can everywhere be moved in LAA in device deployed position and when the anchor portion is in the anchor non-deployed position, Multiple and different positions in LAA are reached, to determine the choosing of the closer part at the optimum position for being located in LAA The optimum position of selecting property anchoring.

Such as by the detailed description illustrated from below it will be evident that these different embodiments may include other component, spy Sign or action.In addition, other embodiment, configuration and process are illustrated in detailed description of the invention below.

Description of the drawings

When reading following detailed description and with reference to attached drawing, foregoing and other advantage of the invention will be apparent, Wherein：

Fig. 1 is the side view of medical device delivery system according to an embodiment of the invention；

Figure 1A is the medical treatment device according to an embodiment of the invention being used together with the medical device delivery system of Fig. 1 Side view depicts the device being implanted in left auricle of heart；

Fig. 2 is the stereogram of the medical treatment device of Figure 1A according to an embodiment of the invention, is depicted at complete extension bits Medical treatment device in setting；

Fig. 3 is the side view of the medical treatment device of Fig. 2；

Fig. 3 A are the sectional views of the medical treatment device of Fig. 3；

Fig. 3 B are the enlarged drawings of the central part system of Fig. 3 A；

Fig. 4 A to Fig. 4 D are the side views of the medical treatment device of Fig. 2 and Fig. 3 according to an embodiment of the invention, depict and pass through Medical treatment device is deployed in the various stages in the left auricle of heart of heart by medical device delivery system；

Fig. 5 A are the side views of the closer frame section of medical treatment device according to an embodiment of the invention；

Fig. 5 B be according to another embodiment of the present invention, the closer frame section of Fig. 5 A that is connected in loop system Side view；

Fig. 5 C are the stereograms of closer frame according to an embodiment of the invention；

Fig. 6 A and Fig. 6 B are the side views of the anchor frame section of anchor system according to an embodiment of the invention；

Fig. 6 C are the anchor systems according to an embodiment of the invention using frame section shown in Fig. 6 A and Fig. 6 B Stereogram；

Fig. 7 A and Fig. 7 B are anchor frame section and closer frame section according to another embodiment of the present invention respectively The side view of section；

Fig. 7 C are the stereograms of the frame of medical treatment device according to an embodiment of the invention, are depicted respectively in Fig. 7 A and figure Multiple anchor frame sections and closer frame section shown in 7B；

Fig. 8 is the sectional view of the medical treatment device of Fig. 7 C；

Fig. 8 A are the amplification sectional views of the central part system of the medical treatment device of Fig. 8 according to an embodiment of the invention, are also retouched The distal portions of transport system are painted；

Fig. 9 A and Fig. 9 B are the proximally and distally stereograms of medical treatment device according to another embodiment of the present invention；

Figure 10 A are the side views of the closer frame section of medical treatment device shown in Fig. 9 A and Fig. 9 B according to the present invention Figure；

Figure 10 B are the side views of closer frame section according to the present invention, depict and are attached to closer frame section On tissue growth component a part；

Figure 11 A to Figure 11 C are the anchor frame sections of medical treatment device shown in Fig. 9 A and Fig. 9 B according to the present invention Side view；

Figure 12 A are the enlarged drawings of the details " 12A " according to an embodiment of the invention obtained from Figure 11 A, are depicted The engagement member extended from anchor frame section；

Figure 12 B are another embodiments of anchor frame section according to an embodiment of the invention, are depicted around anchor The line of frame section winding；

Figure 13 is the stereogram of anchor central part system according to an embodiment of the invention；

Figure 14 A and Figure 14 B are the phases with the central part system interconnection of medical treatment device according to an embodiment of the invention The side cross-sectional view of the anchor frame section and closer frame section answered；

Figure 15 is the end-view of the ring according to an embodiment of the invention used in the central part system of Figure 14 A；

Figure 16 is the stereogram of the medical treatment device (not having tissue growth component) of Fig. 9 A and Fig. 9 B according to the present invention；

Figure 17 A and Figure 17 B are the proximally and distally stereograms of medical treatment device according to another embodiment of the present invention；

Figure 18 A and Figure 18 B are the proximally and distally stereograms of medical treatment device according to an embodiment of the invention, are depicted more A tissue growth component and layer；

Figure 19 is the sectional view of a part for medical treatment device according to an embodiment of the invention, depicts and is attached with central part The anchor central part of tissue growth component；

Figure 20 is the side view of the single anchor section of anchoring system according to an embodiment of the invention, is depicted The dissolving component (dissolving member) of anchor portion bearing to anchor section is provided；

Figure 20 A are the amplifications of the dissolving component in the anchor section according to an embodiment of the invention for being connected to Figure 20 Figure；

Figure 21 is the vertical of the medical treatment device according to an embodiment of the invention being connected in medical device delivery system Body figure, the steerable system being depicted in the first actuated position；

Figure 21 A are the medical treatment device of Figure 21 according to an embodiment of the invention and the sectional perspective of medical device delivery system Figure, depicts the medical treatment device that anchor portion is disposed when steerable system is in the second actuated position；

Figure 21 B are the medical treatment device of Figure 21 according to an embodiment of the invention and the sectional perspective of medical device delivery system Figure, depicts the medical treatment device that tether is disposed when steerable system is in third actuated position；

Figure 21 C are that the amplification of the conduit system of the line 21C interceptions along Figure 21 according to another embodiment of the present invention is cut Face figure；

Figure 22 is the proximal end view of the steerable system of Figure 21 according to an embodiment of the invention；

Figure 23 is the sectional view for the steerable system that the line 23 according to an embodiment of the invention along Figure 22 intercepts, and is depicted Steerable system in the first actuated position；

Figure 23 A are the sectional views of the steerable system of the line 23A interceptions according to an embodiment of the invention along Figure 23, are described The mode switch of steerable system；

Figure 24 is the sectional bottom-view for the steerable system that the line 24 according to an embodiment of the invention along Figure 22 intercepts, and is retouched The steerable system in the first actuated position is painted；

Figure 24 A are the floating for the steerable system that the details " 24A " according to an embodiment of the invention from Figure 24 obtains (float) amplification sectional view of actuating element；

Figure 24 B are the closer behaviour for the steerable system that the details " 24B " according to an embodiment of the invention from Figure 24 obtains The amplification sectional view of vertical part；

Figure 24 C are the anchor behaviour for the steerable system that the details " 24C " according to an embodiment of the invention from Figure 24 obtains The amplification sectional view of vertical part；

Figure 25 is the side cross-sectional view of steerable system according to another embodiment of the present invention, is depicted at the second manipulation Steerable system in position；

Figure 25 A are the sections of the steerable system of section line " 25A " interception according to an embodiment of the invention along Figure 25 Figure；

Figure 26 is the side cross-sectional view of steerable system according to an embodiment of the invention, is depicted at third actuated position In steerable system；

Figure 26 A are the sections of the steerable system of section line " 26A " interception according to an embodiment of the invention along Figure 26 Figure；

Figure 27 is the proximal end view of steerable system according to an embodiment of the invention, is depicted at releasing in releasing position It puts and allows to switch；

Figure 28 is the side cross-sectional view of the steerable system intercepted along the section line " 28 " of Figure 27；

Figure 28 A are the sectional views of the steerable system intercepted along the section line " 28A " of Figure 28；

Figure 29 is the sectional bottom-view of the steerable system intercepted along the section line " 29 " of Figure 27, is depicted at release position Steerable system in setting；

Figure 30 is the amplification side cross-sectional view of the proximal part of the steerable system intercepted along the section line " 30 " of Figure 22, is retouched The end part of the steerable system before releasing position is painted；

Figure 31 is the amplification stereogram of the proximal part of steerable system, is depicted before releasing position and steerable system The unshowned steerable system of outer housing；

Figure 32 is the amplification side cross-sectional view of the proximal part of the steerable system intercepted along the section line " 32 " of Figure 27, is retouched It has painted in the releasing position and the unshowned steerable system of outer housing of steerable system；

Figure 33 is the amplification stereogram of the proximal part of the anchor actuating element of steerable system, is depicted at release position In setting and the unshowned steerable system of the outer housing of anchor actuating element；

Figure 34 is that (behaviour is not shown for the sake of clear and is convenient in the amplification stereogram of the closer actuating element of steerable system Vertical outer housing), the closer actuating element being depicted in unreleased position；

Figure 34 A are that the amplification of the closer release slider obtained from the details " 34A " of Figure 34 and a part for release lever is stood Body figure；

The amplification stereogram of a part for the release lever that Figure 34 B are obtained from the details " 34B " of Figure 34；

Figure 35 is that (manipulation is not shown for the sake of clear and is convenient in the amplification stereogram of closer release slider and release lever Outer housing), closer release slider and the release lever being depicted in releasing position；

Figure 35 A are the spine for the closer release slider that the details " 35A " according to an embodiment of the invention from Figure 35 obtains The amplification stereogram of pawl and release lever；

Figure 36 is that the amplification according to an embodiment of the invention that the medical treatment device across sheath is pushed by conduit system is cut Face figure；

Figure 37 is that the amplification of the closer part of the medical treatment device according to an embodiment of the invention disposed from sheath is cut Face figure；

Figure 38 is the amplification sectional view of anchor portion according to an embodiment of the invention, wherein being disposed by conduit system The closer part of medical treatment device；

Figure 38 A are the amplification sectional views of the conduit system and sheath according to an embodiment of the invention intercepted from line 38A；

Figure 39 is the amplification sectional view of the interconnection according to an embodiment of the invention between medical treatment device and tether line；

Figure 40 is the amplification section of the medical treatment device disposed by conduit system and tether according to an embodiment of the invention Figure；

Figure 41 is the partial perspective view according to an embodiment of the invention for pivoting (articulating) conduit, depicts and leads The distal portions of pipe；

Figure 41 A are the distal portions of the pivot conduit according to an embodiment of the invention obtained from the section 41A of Figure 41 Amplification stereogram；

Figure 42 is the side view of pivot manoeuvre system according to an embodiment of the invention；

Figure 42 A are the amplification sections of the pivot manoeuvre system according to an embodiment of the invention intercepted from the line 42A of Figure 42 Figure；

Figure 43 is the stereogram of deflection component according to an embodiment of the invention；

Figure 44 is the sectional view for the wire bonding component that the line 44 according to an embodiment of the invention along Figure 42 intercepts；

Figure 45 is the partial cross-sectional view of medical treatment device according to another embodiment of the present invention；

Figure 46 is the partial cross-sectional view of medical treatment device according to still another embodiment of the invention；

Figure 47 is the partial cross-sectional view of medical treatment device according to still another embodiment of the invention.

Specific implementation mode

Referring to Fig.1 and Figure 1A, it discloses and can be used for occluding or correct opening or cavity 5 (such as left auricle of heart (LAA)) Medical apparatus system 10.In one embodiment, medical apparatus system 10 may include the behaviour with one or more actuators Indulge 12 and fluid port 14.In addition, system 10 may include conduit 16, which, which has, extends longitudinally through conduit therein Lumen and the distal portion for being attached to manipulation 12.The conduit lumen can be coincided and be connected to lumen is manipulated and and fluid end Mouth 14 is connected to.

It can be structured as making to be arranged the medical treatment device 40 in the distal portions 20 of conduit 16 with the actuator being connected is manipulated Actuating or movement, to dispose medical treatment device 40 from the distal portions 20 of conduit 16 or dispose medical treatment dress in the distal portions of conduit It sets, (capturing again) medical treatment device 40 is captured in the distal portions 20 of conduit, or execute the two.The medical treatment device 40 can Via tether coil or other structures or element (being commonly referred to as tether for the sake of the herein for convenience) (figure for extending through conduit 16 Tether is not shown in 1 and Figure 1A) it is interconnected with manipulation 12.For example, tether can have with manipulate 12 close ends that are connected and its with The connected distal portion of medical treatment device 40.It can be by controlling the movement of tether/coil (via actuator) and controlling tether 16 Movement with operated in the different stages with dispose and capture medical treatment device 40 again.

(wherein device is complete or at least apparent extension to medical treatment device 40 shown in Figure 1A in deployed position ) may include closer system 42 and anchor system 44.As described in briefly above, medical treatment device 40 can be controlled as Each individual stage is disposed, one of phase deployment closer system 42 and another independent phase deployment anchor system System 44.In this manner, doctor can dispose closer system 42 first, preferred position of the closer system 44 in LAA 5 is determined It sets and direction, and once satisfactorily positions and orient, doctor is just able to maintain that anchor system is concurrently and independently disposed in the position System 44.Closer system 42 and anchor system 44 are configured to individual, master by doctor or the operator of system 10 as a result, Dynamic action and disposed independently of one another.

It has been observed that it may include multiple actuators to manipulate 12, multiple actuator includes relieving mechanism 32.Relieving mechanism 32 It is configured to discharge medical treatment device 40 from conduit once medical treatment device 40 is anchored in LAA 5, it such as will be further detailed below As thin discussion.As shown in fig. 1, other actuators may include the first actuator 22, the second actuator 24, third actuating Device 26, the 4th actuator 28 and the 5th actuator 30.For example, the first actuator 22 and the second actuator 24 are it is so structured that control The movement of closer system 42, and third actuator 26 and the 4th actuator 28 are it is so structured that control the fortune of anchor system 44 It is dynamic.5th actuator 30 is it is so structured that when the distal portions 20 that medical treatment device 40 is arranged in time control conduit 16 in LAA 5 Navigability, by tight comers and to be conducive to orient.It should be noted that for example, the first actuator 22 and second activates Device 24 can be configured to or as the single actuator for closer system 42.Similarly, third actuator 26 and the 4th causes Dynamic device 28 can be configured to or as the single actuator for anchor system 44.

With reference to Fig. 2, Fig. 3 and Fig. 3 A, closer system 42 may include being connected to closer central part system 46 and tissue Grow the closer frame 43 on component 48.Closer frame 43 includes showing spoke-like structure greatly from closer central part system 46 The multiple closer frame sections 50 type radial direction and extended to distal end.The closer frame 43 is configured to both aid in tissue growth structures The contraction for extending also aid in tissue growth component 48 of part 48.Each frame section 50 may include expander part 52 as a result, With constrictor part 54, wherein expander part 52 can include the total length bigger than the total length of constrictor part 54.For example, When compared with constrictor part 54, each expander part 52 can extend to it is radial it is farther, to distal end it is farther or this two Person.

In addition, each frame section 50 may include in each being located in expander part 52 and constrictor part 54 Fixture 56.Fixture 56 can be used for tissue growth component 48 being attached between expander part 52 and constrictor part 54. The fixture 56 is respectively illustrated at open position (Fig. 3 A), but works as tissue growth component 48 being attached to closer frame 43 When, fixture 56 moves to closed position, as as shown in arrow 58.In this manner, tissue growth component 48 can be easy Ground is attached to closer frame 43.

Tissue growth component 48 may include the porous structure for being configured to be led to or promote tissue growth, or be configured to promote Other arbitrary suitable structures of tissue growth.Tissue growth component 48 can include for example cup-shaped shape, have appearance The ontology or structure in face 60 and inner surface 62.Outer surface 60 may include distal surface portion 64 and proximal end face part 66.Group Knitting the distal surface portion 64 of the outer surface of growth component 48 can be sized to and be configured to straight with the tissue wall 7 in LAA 5 It contacts (referring to Figure 1A).In one embodiment, tissue growth component 48 is it is so structured that from constraint configuration or deflation configuration From expanding to expanded configuration or guidewire lumen.In one embodiment, tissue growth component 48 may include polymer material, than Such as polyurethane foamed material.Can also use with desired porosity other materials, such as felt, fabric, Nitinol (Nitinol) litzendraht wire or polymer felt or Nitinol felt.In the case of foamed material, which can be Reticulated foam is typically subjected to being chemically treated or being heat-treated to open foamed material as known to persons skilled in the art Interior hole.Foamed material can also be non-mesh foamed material.In one embodiment, foamed material may include desired point Grade density or hierarchical porosity, and be manipulated to when framing component moves to expanded configuration to be extended to desired shape.

In another embodiment, tissue growth component 48 may include polyurethane foam, have outer on inner surface 62 Skin structure (skin structure), the skin construction on outer surface 60 or skin construction on both surfaces.Example Such as, skin construction can be formed on inner surface 62 and be configured to that blood is inhibited to flow through tissue growth component 48, and organize life The outer surface 60 of long component in its hole it is so structured that receiving blood cell and being led to tissue growth.In one embodiment In, which can include the layer of the material of such as tantalum, which is splashed on the surface of tissue growth component 48. In another embodiment, skin construction can include polyurethane foam crust.Another example includes by expanded PTFE (ePTFE) it is attached on the outer surface 60 or inner surface 62 of tissue growth component 48, ePTFE has minimum porosity with basic Blood flow is inhibited to still allow for its endothelialization (endothealization) simultaneously.

In one embodiment, anchor system 44 may include anchor central part system 70 and multiple anchor portions Part.Anchor central part system 70 it is so structured that be located in and be arranged closer central part system 46 it is interior or with the closer Central part system is adjacent.Multiple anchor components can include such as the first anchor component 72 and the second anchor component 74. Each in first anchor component 72 and the second anchor component 74 may include stepping on valve or ring configuration (Fig. 2, Fig. 3, figure It is illustrated at expanded configuration in 3A, Fig. 6 A and Fig. 6 B), wherein for example two ring configurations are used for the first and second anchor portions Each in part 72 and 74, the two rings are interconnected to one via anchor central part system 70 (being discussed in more detail below) It rises.Each ring can be (that is, in figure 2 and figure 3 shown in embodiment, be anchored vertical with adjacent ring with primary orientation Each ring of device component 72 ring adjacent with anchor component 74 is vertical).Note that as used herein, term " ring Circle " need not be formed closed curve by component, but the curve of base closed or the part with curve return to itself Open curve can also be considered as " ring ".

When in expanded configuration, each ring may be located remotely from the extension of closer system 42, and extend radially outwardly To the configuration bigger than anchor central part system 70.In other words, it is cut along the longitudinal axis 75 extended through central part system 70 In the section taken, at least part of anchor component 72 and 74 is to the distal end for distally extending beyond closer system 42 Point, and the farthest part of radial direction for extending radially beyond closer system.Each ring in anchor component 72 and 74 may be used also To include engagement member or traction lug (nub) 78 on the outer peripheral edge of ring configuration, traction lug 78 be sized to and It is configured to engage with the tissue wall 7 in LAA 5 and promptly tissue wall 7 (referring to Figure 1A).In one embodiment, lug is drawn 78 with tissue wall 7 it is so structured that effectively engaging but not piercing through or penetrate tissue.The traction lug can be structured as nothing as a result, Wound structure.

In the ring configuration of first anchor component 72 each it is substantially coplanar each other when in expanded configuration and Configuration in substantially flat.Similarly, each in the ring configuration of the second anchor component 74 is in expanded configuration Configuration constantly substantially coplanar each other and in substantially flat.In one embodiment, the first anchor component 72 can be attached It is connected to the second anchor component 74 so that the ring configuration orientation between the first anchor component 72 and the second anchor component 74 It is substantially perpendicular to each other.In other words, the plane that the first anchor component 72 is positioned or oriented and the second anchor component 74 Plane is substantially vertical.In other embodiments, it may be equipped with more than two anchor component, in this case, these anchorings Device component may or may not be oriented in a manner of substantially vertical relative to each other.

With reference to Fig. 3 A and Fig. 3 B, medical apparatus system 10 includes multiple conduits or tubular element and tether system to manipulate The movement and deployment of closer system 42 and anchor system 44.For example, main pipe 16 or outer catheter may include being located in Extend wherein and substantially the first tubular element 80 and the second tubular element 82 of its longitudinal length.The tubular element can be conduit Component, coil (coiled) component or other arbitrary suitable tubular elements as known in the art.In addition, it has been observed that medical treatment Apparatus system 10 may include the first tether system 84 and the second tether system 86, and the first tether system 84 is configured to be to occlusion In device system 42 and the second tether system 86 is configured to tie in anchor system 44.Tether system 84 and 86 may include for example Extend through one or more line of coil component.In one embodiment, thermal polycondensation object material can also be in coil component Upper formation.

It has been observed that closer system 42 may include multiple closer frame sections 50,46 and of closer central part system Tissue growth component 48.Each closer frame section 50 may include base segments 90, expander part 52 and constrictor portion Divide 54.Base segments 90 may include distal base portion part 92 and proximal base part 94.Proximal base part 94 may include Attachment point such as tether eyelet 98.In addition, expander part 52 and constrictor part 54 can be from each closer frame sections 50 proximal base part 94 radially extends and can also be from the proximal base part 94 of each closer frame section to remote End extends.

Distal base portion part 92 may include recess 96, which is sized to and is configured to reception ring to form closer Central part system 46.In one embodiment, ring may include such as two outer shrouds 100 and one or more inner ring 102 placed in the middle, Each it is positioned as and is interconnected to each base segments of closer frame section 50 to form closer central part system 46.It is logical The arrangement is crossed, closer system 42 can be disposed from main pipe 16, wherein a part for the first tether system 84 is in proximal end base It is attached at portion part 94 on tether eyelet 98.Although being not shown in Fig. 3 B, the deployment of closer system 42 can be in anchor Determine to carry out when device system 44 is still retracted in the first tubular element 80 so that only closer system 42 is disposed.If desired, closing Plug device system 42 can also be retracted into the distal portions 20 of main pipe 16, such as with block system device system 42 in LAA 5 Repositioning.In this manner, doctor can be deployed in LAA at desired position and on desired direction by closer system 42 In 5, while also being maintained to the close of closer system 42 via the first tether system 84.

As indicated previously, anchor system 44 may include anchor central part system 70, the first anchor section 72 With the second anchor section 74, wherein each anchor section 72 and 74 when in expanded configuration include two ring structures Type.Each in ring may include first end section 104 and second end section 106 and be located at the first end and institute State the centering portions 108 between the second end.Centering portions 108 include engagement lug or traction lug 78, for example are previously illustrated As.When anchor system 44 is in deployable state, the first end section 104 of ring can prolong from base segments 112 It stretches, and second end section 106 can be interlocked with anchor central part system 70, which includes that setting is being closed It fills in device central part system 46 or the multiple rings 110 adjacent with the closer central part system.First anchor section 72 it is every The first end section 104 of a ring can respectively extend from its base segments 112.Similarly, each ring of the second anchor section 74 First end section 104 can respectively from the base segments 112 of the second anchor section 74 extend.

The base segments 112 of each in first and second anchor sections 72 and 74 can be interlocked or are coupled together And it is configured to be located in ring 110 or (when in guidewire lumen) adjacent with the ring and can be towards retracting or non-portion Administration position moves to the proximal location in the first tubular element 80.The base segments 112 are configured to via eyelet 114 or in base portion Other structures in part 112 are tied onto the second tether system 86.In addition, base segments 112 can be in the first tubular portion 80 It is interior, moved between retracted position and deployed position.In retracted position, base segments 112 are located in the first tubular element 80 In proximal end, wherein the major part of each in the first and second anchor sections 72 and 74 is rolled to the first tubular element 80 It is interior so that " ring " of anchoring section 72 and 74 partly has tighter curve or smaller radius.In addition, in retracted position In, anchor central part system 70 can also be moved close to closer central part system 46, this is because the two systems can It acts independently of one another.When making anchor system 44 move to deployed position, anchor central part system 70 can be to distal end Movement is with via the stopper section 116 being limited on the second end section 106 of anchor section 72 and 74 and closer central part system A part for system 46 is engaged or is abutted, and after this, the base segments 112 of anchor section 72 and 74 can be relative to first Tubular element 80 or main pipe distal movement, the rolling of subsequent anchor system 44 leave main pipe 16 so that ring extends to portion Affix one's name to position.In another embodiment, the second end section of anchor section 72 and 74 can be in deployable state and retracted mode Remain adjacent with closer central part system, while base segments are shifted relative to closer central part system 46 for portion Affix one's name to anchor system 44.In any configuration, doctor via second tether system 86 maintain to anchor system 44 close to and Control, and so can determine that whether medical treatment device 40 is positioned correctly, or if can be by making anchoring without if 112 proximal movement of base segments of device section by the major part of anchor section 72 and 74 to be rolled to the first tubular element 80 It is interior and anchor system 44 is made easily to retract.

With reference to Fig. 4 A to Fig. 4 D, medical treatment device 40 is shown as just being deployed in LAA 5, mainly uses two-phase deployment side Method, wherein closer system 42 are disposed and then anchor system 44 is disposed.Reference Fig. 4 A, medical apparatus system 10 The distal portions 20 of conduit 16 advance to LAA 5.As indicated by dashed line, if desired, can manipulate and operate distal portions 20 into Row racing is to approach LAA 5 or the region adjacent with LAA 5.This can such as by activate the 5th actuator 30 (Fig. 1) by Implement, the 5th actuator can be structured as the distal portions 20 for being suitably orientated conduit 16 and obtain the advantageous of the distal portions Initial position.For example, the 5th actuator 30 could be attached to cable 120, which is attached to fixed point or block 122 again, Distal end of the block in region 124 (in the distal portions 20 of conduit 16, which needs to be bent).In one embodiment, Material at the bending region 124 of main pipe 16 can be softened or thinning so that when cable 120 is via the 5th actuator 30 When pulled, main pipe 16 will be bent at the region of softening or thinning material.This can also be via pulling cable and/or promotion Cable is realized, wherein pushing cable for example with the coil being used therewith.

With reference to Fig. 4 B, it is (most that closer system 42 is shown as the deployment from the distal portions 20 of medical device delivery system 10 Pipe anchor system 44 is not yet disposed).Before disposing closer system 42, doctor can be in the far-end of the arteries and veins mouth 9 of LAA 5 Initially operate the distal portions 20 of transport system 10.Once being in advantageous position, doctor can dispose closer system 42 and subsequent ideal side of the proximal movement closer system until obtaining closer system 42 in LAA5 in LAA 5 To and position.With reference to Fig. 3 B, closer system 42 can be for example by maintaining closer system 42 via the first tether system 84 Position and make main pipe 16 relative to closer system 42 retract and disposed.Can for example by shape-memory material (such as Be discussed in further detail below) the closer frame that is formed when can then be extracted from main pipe 16 at it from extension.With Which, 64 radial expansion of distal surface portion of the outer surface 60 of tissue growth component 48 with the tissue wall 7 of LAA 5 to connect It touches.

With reference to Fig. 4 C, once doctor obtain in LAA 5 ideal position (its can be the position and direction in addition to shown in Outer position and direction), doctor can then begin to deployment anchor system 44 while maintain closer system 42 in LAA 5 Position.It, can be by starting to dispose anchor system as follows when in the chosen position during block system 42 to be maintained to LAA 5 System 44：Make anchor central part system 70 relative to closer central part system 46 move and via the second tether system 86 to Distal end push anchor system 44 base segments 112, with thus make anchor section 72 and 74 rolling leave main pipe 16 or First tubular element 80 and enter extension ring configuration (referring to Fig. 3 B).

Once the base segments 112 of the first and second anchor sections 72 and 74 move to complete remote location, i.e., and anchor It is adjacent to determine device central part system 70, anchor system 44 is then just fully deployed, as described in Fig. 3, Fig. 3 A and Fig. 4 D Like that.In the position, main pipe 16 and the first tubular element 80 and the second tubular element 82 can retract and only first and Two tether systems 84 and 86 maintain to be connected or be close with corresponding closer system 42 and anchor system 44.If doctor is full It is intended to direction and position of the medical treatment device 40 in LAA, then then can discharges (the figure of medical treatment device 40 via relieving mechanism 32 1).But if doctor is dissatisfied, anchor system 44 and closer system 42 then can be correspondingly reloaded into leading In the distal portions 20 of pipe 16.Doctor then can follow aforementioned mistake again using identical medical treatment device 40 and transport system 10 Another trial of Cheng Jinhang.It is noted that doctor can monitor placement and the portion of medical treatment device 40 using various imaging techniques Administration.For example, doctor can be contrasted via imaging technique as known in the art in LAA to observe the position of medical treatment device 40 It sets.

Referring now to Fig. 5 A to Fig. 5 C, the various parts of closer system 42 are shown in Fig. 5 A and Fig. 5 B, and in Fig. 5 C Show the component of closer system 42 according to an embodiment of the invention.With reference to Fig. 5 A, a closer frame section 50 is shown Go out be include each one in base segments 90, expander part 52 and constrictor part 54.Closer system 42 may include Such as four frame sections, but may include more or less than four in other embodiments.In a specific embodiment, Eight frame sections 50 may be used.Each frame section 50 can be for example cut by laser from Nitinol plate, have such as Such as in fig. 5 shown in preferred expanding location completely shape and design.In this embodiment, each frame section can To be formed as substantially planar component, or in other words, there is substantially planar configuration.As described in Fig. 5 B and Fig. 5 C, often A closer frame section 50 is assembled into ring or center parts 46, may include such as two outer shrouds 100 and an inner ring 102.Ring 100 and 102 may include recess (being not shown in Fig. 5 B or Fig. 5 C) so that each in frame section 50 is along ring Inner peripheral and/or outer peripheral edge orient and position at desired radial position.

For simplicity, only one frame section and ring assemblies are shown in cross section in figure 5B, but such as Fig. 5 C Shown in, closer system 42 can include around ring 100 and 102 with the more of desired pattern or geometric configuration radial positioning A frame section 50.The combination of the multiple base segments 90 and ring 100 and 102 of each closer frame section 50 is formed in closer Center portion system 46.In addition, closer central part system 46 is sized to and is configured to be conducive to anchor system (Fig. 5 A- Fig. 5 C In be not shown) at least part pass through the opening (for example, pass through ring) of closer central part system 46.By the arrangement, if It needs, each component of closer system 42 can be from marmem plate (for example, Nitinol, also referred to as Nitinol) plate It is cut by laser, including ring 100 and 102.In other embodiments, the various parts of central part system can use polymer Or other metal materials are formed and are machined out using typical technology and methods.In addition, not all component is required for It is formed by identical material or using identical manufacturing process.For example, in one embodiment, frame section 50 can be as above-mentioned Ground is formed by cutting them from Nitinol plate, and ring 100 and 102 passes through moulding process shape by polymer material At.

Turning now to Fig. 6 A to Fig. 6 C, the component of the anchor frame section of anchor system 44 is shown.First anchoring Device section 72 (Fig. 6 A) and the second anchor section 74 (Fig. 6 B) include respectively first end section 104 and second end section 106, and first End part 104 from base segments 112 extend and centering portions 108 between first end section 104 and second end section 106. When in expanding location (as shown in figs. 6 a and 6b), each anchor section 72 and 74 can limit one or more Ring configuration.For example, embodiment shown in Fig. 6 A and Fig. 6 B includes respectively two rings.

The base segments 112 of first anchor section 72 include extending through opening therein or hole 118.118 scale of hole It is very little to be and be configured to receive the inner edge portion 120 of the second anchor section 74.By the arrangement, the first anchor section 72 is fixed To for and be located on the direction vertical with the second anchor section 74 (referring to Fig. 6 C) so that the second anchor section 74 it is interior Marginal portion 120 is engaged with the hole 118 of the first anchor section 72.

It is further noted that first end section 104 on thickness along its towards second end section 106 extend length gradually It contracts or tapered at least partially along its length of curve.Tapered elasticity and the extension feature of providing is to maintain anchor station (that is, deployed position of anchor section 72 and 74).In addition, second end section 106 includes recess configuration, the recess configuration scale It is very little to be and be configured to reception ring 110 to form anchor central part system 70.As previously illustrated, anchor central part system 70 Be sized to and be configured to be located in when complete deployment in closer central part system (being not shown in Fig. 6 A- Fig. 6 C) or with close It is adjacent to fill in device central part system.The base segments 112 of second anchor section 74 are also sized to and are configured to receive close around it The ring element 122 of end.As closer system 40, anchor section 72 and 74 and ring 110 can from it is desired completely The nitinol material plate of the shape of expanded configuration is cut by laser.In this embodiment, each frame section 72 and 74 can be with Be formed as substantially planar component, or in other words, there is substantially planar configuration.In this manner, it is possible to be formed and be assembled into Anchor system 44.Certainly, the component of anchor system 44 can be formed by other materials, using other manufacturing process, such as be existed Be previously with regard to closer system 40 by discussion as.

Referring now to Fig. 7 A, Fig. 7 B, Fig. 7 C, Fig. 8 and Fig. 8 A, it is used to occlude the another of the medical treatment device of opening such as LAA Embodiment is shown.The embodiment is similar to previously described embodiment, in addition in this embodiment, anchor section is occlusion The extension of the base segments of device frame section.In other words, anchor frame section and closer frame section are integral with one another, Although still maintaining the independent deployment and retraction of closer system and anchor system.

Referring initially to Fig. 7 A, frame section 210 is shown as including anchor section 212 integral with one another and closer Section 214.Anchor section 212 and closer section 214 are single-piece or single type, and for example can be from expectation Material such as nitinol material plate with laser cutting made of single frame section.Anchor section 212 includes first end Part 222, second end section 224 and the centering portions 226 between the first end and the second end.First end Part 222 extends from anchor base portion 228 and when it extends towards second end section 224 at least partially along its curve Length is tapered on thickness.Centering portions 226 may include be configured to when in extension, in guidewire lumen when and LAA tissue Wall engages the engagement lug or traction lug 234 of (but need not pierce through).Second end section 224 is from closer section 214 The distal portion 232 of base segments 220 extends.

Expander part 216 and constrictor part 218 are from the close end 236 of the base segments 220 of closer section 214 To distal end and extend radially out.It expander part 216 can be to distal end and radially than constrictor part that it is connected 218 extensions are farther.Such as previous in embodiment, expander part 216 and constrictor part 218 are configured to connect between them Receive tissue growth component (being not shown in Fig. 7 A- Fig. 7 C, Fig. 8 or Fig. 8 A).In addition, base segments 220 include recess 230, this is recessed Mouth is sized to and is configured to reception ring so that multiple frame parts are connected, as described below.

With reference to Fig. 7 B, individual closer section 240 is shown.The individual closer frame section 240 can construct It is substantially similar for the closer section 214 (and closer frame section 50 of previous embodiment) to Fig. 7 A, individually except this Closer frame section 240 include frame section 210 as shown in Figure 7A like that from its base segments 220 extend anchor Determine device frame section 212.As described in Fig. 7 C, the frame of medical treatment device includes radial directed and positioning in an alternating fashion Multiple frame sections 210 (Fig. 7 A) and multiple individual closer sections 240 (Fig. 7 B), such as four frame sections 210 and four A individual closer frame section 240.

As front is illustrated, frame section 210 includes closer section 214 and anchor frame section 212.Exist as a result, In Fig. 7 C and embodiment shown in fig. 8, being equipped with total of eight closer frame section, (four of which is individually occlusion Device section 240).But medical treatment device may include fewer or more closer frame sections.Doctor as shown in FIG. 8 Describe in the sectional view of the frame for the treatment of device, the frame section 210 and individual closer frame section 240 (are not shown in Fig. 8 Go out) it can be coupled together via the ring 244 being arranged in the recess 230 of the base segments 220 of closer section 214 to be formed Closer central part.Similarly, the base segments 222 of frame section 212 can be via one or more rings 272 (referring to Fig. 8 A) It is coupled together to form anchor central part.

With reference to Fig. 8 A, the enlarged drawing of the central part system 250 and distal portions 252 of transport system 254 is shown.Delivery system System 254 can be similar to previously described embodiment and includes main pipe 256, the first tubular element 258 and the second tubulose structure Part 260 and the first tether system 262 and the second tether system 264.First tether system 262 is configured in base segments 220 The first eyelet 266 at be connected to closer system.Second tether system 264 is configured to be defined in the second eyelet therein Anchor base portion 228 is connected at 268.In addition, anchor base portion 228 can be interconnected with central part component 270.Central part component 270 it is so structured that allowed line such as guide wire advances through wherein (not shown).

Central part system 250 can also include ring element 272, which, which is configured to be received in, is defined in each anchoring In recess 274 in the anchor base portion 228 of device section 212.It is similar to previous embodiment, anchor system (or at least Its major part) it can be by via the second tether system 264 proximally pulling anchor base portion (as indicated as arrow 276) 228 and be retracted into the first tubular element 258.Anchor system can also be by transport system 254 by disposing as follows：Make anchoring Thus the proximally position distal movement of device base portion 228 makes anchor section 212 be rolled from transport system 254, expand to be formed Ring is opened up, it is similar to previous embodiment.It should also be noted that the medical treatment device of the embodiment can with two sequences or The continuous stage is disposed, similar to being described about previous embodiment.In other words, closer system can be independently of anchor Determine in device system deployment and the desired position and direction that are placed in LAA.Anchor system can be after closer system Deployment is closer system to be fixed in its desired position.

Fig. 9 A and Fig. 9 B show the proximally and distally three-dimensional of another embodiment 300 of medical treatment device according to the present invention Figure.Similar to previously described embodiment, in this embodiment, medical treatment device 300 includes closer system 302 and anchor system System 304, the closer system have tissue growth component 306.Closer system 302 and anchor system 304 can be by being connected Medical device delivery system discretely dispose, such as described in Fig. 1 and Fig. 4 A to Fig. 4 D.But in the implementation In example, closer system 302 and anchor system 304 may include various other features as being described in detail below.Separately Outside, in this embodiment, closer system 302 is shown as including six closer frame sections 310 (different from for example having closed In four or eight of other embodiment description, it is either even up to 12 in another embodiment or is knitted in deployment line In the case of object, the number of frame section being capable of bigger), and anchor system 304 is shown as including three anchor frame sections Section 350 (each anchor frame section has two rollings or ring part).In the same manner, anchor frame section and closer The number of frame section is only another example, and it is further envisaged that going out together with various medical treatment devices described herein makes The frame section of other numbers of used time.Anchor frame section 350 and closer frame section 310 can be positioned as and orient To replace relative to each other.In addition, in this embodiment, closer frame section 310 does not include front and rear above-mentioned Constrictor and expander part, but each closer frame section may include single frame component, tissue growth component 306 It is attached to the single frame component and the single frame component is conducive to the contraction and extension of tissue growth component 306.

0A referring now to fig. 1 for the sake of clarity shows the side view of single closer frame section 310.As above It states, closer system 302 (Fig. 9 B) may include multiple closer frame sections 310, for example be at least partially formed closer Six closer frame sections of system.The closer frame section 310 of the embodiment may include constrictor part 312, expand Open up device part 314 and extension 316 placed in the middle.In addition, closer frame section 310 may include outer surface 318 and inner surface 320.Constrictor part 312 is extended radially outwardly into from the proximal part 322 of closer frame section 310 relative to axis 325 Expander part 314.Similarly radially outward prolong from the end of constrictor part 312 relative to axis 325 expander part 314 Reach the distal portion 324 of closer frame section 310.Extension 316 placed in the middle can be from substantially in the proximal end of expander part 314 At the portion or position adjacent with the close end of the expander part extends radially inwardly, and can be with constrictor part 312 Adjacent part extends in spaced relation so that 320 basic side of inner surface of the adjacent part of constrictor part 312 is to placed in the middle Extension 316.In addition, closer frame section 310 can also include closer base segments 326.Closer base segments 326 May include closer leg extension 328 and protrusion 330, the closer leg extension and protrusion, which define, to be configured to in The interlocking recess 332 of center portion, as will be described in details further below.

0B referring to Fig.1 shows the single closer frame section of the tissue growth component 306 with attachment thereon 310 side view.Tissue growth component 306 may include inner surface 334 and outer surface 336, inner surface 334 and outer surface 336 It is contacted at least partly with the constrictor part 312 of closer frame section 310 and expander part 314.Tissue growth component 306 can extend from the base segments 326 of closer frame section 310 so that the outer surface 336 of tissue growth component 306 with The inner surface 320 of the constrictor part 312 of closer frame section 310 is in contact.In addition, closer frame section 310 can be with Extend through tissue growth component 306 so that the outer surface 318 of expander part 314 can in tissue growth component 306 Surface 334 is in contact.

By the arrangement, extension 316 placed in the middle extends radially inwardly so that tissue growth component 306 is located in constrictor Between a part for part 312 and extension placed in the middle 316.Extension 316 placed in the middle can be assisted tissue growth component as a result, 306 are held in or are attached to closer frame section 310.When closer system 302 in the catheter when pulled, constrictor part 312 outer surface 318 can be in contact with the inner surface of conduit lumen and the contraction of aid in tissue growth component 306.It is similar Ground, when from catheter deployment closer system 302, the outer surface 318 of expander part 314 is configured to aid in tissue growth component 306 expand to position similar with position is described (it is noted that showing tissue growth component 316 in Figure 10 B with cross-sectional view The only first half).

Tissue growth component 306 can also include multiple material layers.In various embodiments, these layers may include passing through Binder or the similar or different material combined by heat treatment or other suitable techniques as known in the art Material.These other layers may include the expanded PTFE on the outer surface for the main layer for being for example attached to tissue growth component (ePTFE).In one embodiment, tissue growth component 306 may include as illustrated in embodiment previous by poly- ammonia The main layer 306A of ester formation of foam.Tissue growth component can also include the other material (such as ePTFE) of thermal each other Layer 306B-306D.In a specific example, outermost or nearest end layer 306C and 306D can be by with internode distances The ePTFE material that (internodal distance) (sometimes referred to as aperture) is about 70 μm to about 90 μm is formed.With main layer Material layer (306B) adjacent 306A can be by having the internode reduced relative to one or more of outer layer 306C and 306D The ePTFE material of distance is formed.For example, the internode distance of this layer of 306B can be about 10 μm.This layer of 306B can use viscous Enclosure material combines or is attached to main layer.The ePTFE layers of other arbitrary suitable dimensions may be used, such as reach with internode distance About 250 μm of ePTFE.

The configuration is effectively prevented passing through for blood due to the small internode distance and aperture of layer 306B, while other layers The big internode distance of (such as 306C and 306D) allows tissue growth and endothelialization to occur.In addition, being formed by polyurethane material Main layer allow tissue promptly to be grown into tissue growth component 306 from LAA walls.It is noted that main layer 306A with it is next Between adjacent layer 306B using suitable adhesion material can be also used for filling next adjacent layer 306B hole and further Blood is inhibited to flow through tissue growth component 306.

1A, Figure 11 B and Figure 11 C referring to Fig.1 show the component of anchor system 304, including the first anchor section 350a (Figure 11 A), the second anchor section 350b (Figure 11 B) and third anchor section 350c (Figure 11 C), are respectively illustrated at Expanded configuration.Each anchor section 350a-350c may include the first anchor portion 352 and the second anchor portion 354, Each can be essentially identical.Each in first and second anchor portions 352 and 354 is in the first outer end 356 and second extend between inner end 358, and the first outer end 356 extends from the position adjacent with anchor leg extension 360. Second inner end 358 extends from anchor central part base portion 362.Anchor leg extension 360 can slightly radially inwardly (direction The longitudinal axis 325 of tissue) and extend far from free end 364.First outer end 356 of anchor section part 352 and 354 It can also include proximal protrusion portion 366.Proximal protrusion portion 366 can be limited with itself or together with a part for leg extension 360 Determine recess 368.Recess 368 and anchor leg extension 360 and the relationship of they and other component will hereinafter further It is discussed in detail.

Anchor central part base portion 362 can be in structure in the first anchor section 350a, the second anchor section It is changed in each in 350b and third anchor section 350c, to respectively include the first anchor central part base portion 362a, the second anchor central part base portion 362b and third anchor central part base portion 362c.Each anchor central part base portion In this structure change can be used for being conducive to the interconnection between individual anchor central part base portion 362a-362c so that The anchor central part system 370 (in Figure 13 best seen from) being described in further detail in being at least partially formed below.

Such as explaination, each anchor section 350-350c may include the first anchor portion 352 and the second anchor Part 354, they can be respectively formed the first ring configuration and the second ring configuration when in expanded configuration.Such as previous Embodiment in, the first and second anchor portions respectively include engagement member 372 or protrusion lug, the engagement member or protrusion are convex Piece is sized to and is configured to be arranged in the first and second anchor portions 352 when anchor frame section 350 extends completely With 354 in the distal side of each at and outer surface on so that the first and second anchor portions 352 and 354 are against in LAA Tissue.

2A referring to Fig.1, engagement member 372 may include the configuration for being referred to alternatively as wave crest configuration so that engagement member 372 is fixed To for and be configured to via tapered edges 384 provide with organize traction or engagement, and make engagement member 372 only in medical treatment The proximally facing direction of device (or in other words towards LAA opening or arteries and veins mouth direction on) be subjected to displacement force when it is strong with tissue Ground engages.In addition, this wave crest configuration of engagement member may include the peak portion 374 that transition is edge 384.Engagement member Peak portion 374 or outer surface can be stubbed or blunt.As shown in figure 12a, peak portion can be substantially round Shape, to prevent engagement member 372 from piercing through substantially or penetrate the tissue of LAA.In addition, engagement member 372 may be oriented such that Engagement member 372 can from the distal side of engagement member 372 relative to the surface of anchor portion 352 tangent line with about 100 35 degree of angle α extension, thus further prevent engagement member 372 pierce through tissue and meanwhile also prevent medical treatment device to close The movement at end.

2B referring to Fig.1, in another embodiment, in corresponding anchor frame section 350-350c each each of Anchor portion 352,354 may include line 376 or other slim-lined constructions being wrapped about to form coil configuration.Line 376 can To be extended with coil configuration between First Line coupling part 378 and the second line coupling part 380 (referring to Figure 11 A).Line 376 can To be constructed so that radially-outer surface 382 is located at the inner radial of the height of the peak portion 374 of engagement member 372 and also position In the inner radial (below or) at the edge of engagement member 372 384.In one embodiment, line 376 can be by metal or metal Alloy such as stainless steel or titanium are formed, and but not limited to this, and can be by such as Nitinol, polymer material, plurality of wire members Or other suitable materials of other metals and alloy etc are formed.The line 376 can be used for enhancing to be connect with the tissue in LAA It closes, and in the anchor portion 352 of anchor frame section 350a-350c or 354 tired at any time and rupture feelings Security feature is provided under condition.

Referring back to Figure 11 A, Figure 11 B and Figure 11 C, will provide now and the relevant discussion of anchor central part base portion.Such as It illustrates, the anchor central part base portion 362a-362c for each anchor frame section 350a-350c may include variation Structure, such as the different recess and slit for being sized and constructing, the recess or slit can be conducive to central part base portion 362a- The interconnection of 362c is to form anchor central part system 370 (Figure 13).For example, referring in particular to Figure 11 A, the first anchor central part Basic 362a can limit the first rear recess 390, first and keep recess 392, the first hole 394 and first slit 396 etc..First Rear recess 390 can be limited to two the second inner ends 358 extending from the first and second anchor portions 352 and 354 it Between.First holding recess 392 can be limited at the opposite sides of the centering portions of the first anchor central part base portion 362a In the centering portions.First hole 394 can be defined close to the first holding recess 392, and the first slit 396 can be limited to It, can be relative to extending through at the proximal part 398 of one anchor central part base portion 362a, and as illustrated in figure 11A The longitudinal axis 325 in one rear recess 390 and the first hole 394 forms angle.

1B referring to Fig.1, similar to the first anchor central part base portion 362a, the second anchor central part base portion 362b can be with It defines the second rear recess 402 and second and keeps recess 404.(it is noted that using term " first ", " the in this discussion Two " and " third " be in order to make recess, hole or other features convenience associated with given central part base portion 362a-362c and It is non-to be appointed as being connected with specific central part base portion 362a-362c by the specific reference numeral of recess).In addition, the second anchoring Device central part base portion 362b can define the second deep proximal end recess 406.The second rear recess 402 can be similarly as a result, It is limited to two the second inner ends extended from the first and second anchor portions 352 and 354 of the second anchor section 350b Between 358.Second keeps recess 404 can be in the opposite sides upper limit of the centering portions of the second anchor central part base portion 362b It is scheduled in the centering portions.Second proximal end recess 406 can be defined in the second anchor between the second connecting portion 408 of opposite extension Determine the close end of device central part base portion 362b, and extends from the close end of the second anchor central part base portion, the opposite extension Second connecting portion at least partially define the second holding recess 404.In addition, the second proximal end recess 406 can be sized to and Be configured in the first rear recess 390 for being located in the first anchor central part base portion 362a so that second keep recess 404 with First keeps recess 392 substantially corresponding and alignment, and makes the second rear recess 402 and the first rear recess 390 (referring to figure It 11A) is associated with and corresponding.

1C referring now to fig. 1, third anchor central part base portion 362c may include that there are two base portion extensions 412 for tool Base portion 410.Base portion 410 can be relative to the two of the first and second anchor portions 352 and 354 of third anchor section 350c A second inner end 358 extends transversely with.Two base portion extensions 412 can proximally extend from base portion 410 to provide each other The two opposite pawls 414 faced so that pawl can be in contact with each other when under release conditions.Two base portion extensions 412 and pawl 414 can be as radially outward shifted shown in arrow 416, to limit third proximal end recess 418 jointly.Third Proximal end recess 418 can be sized to and be configured to receive the first rear recess 390 and second of the first central part base portion 362a The second rear recess 402 of central part base portion 362b so that two base portion extensions 412 are in the first anchor central part base portion Extend on 362a and (referring to Figure 11 A and figure in 414 bolt-lock of pawl to the first hole 394 of the first anchor central part base portion 362a 13).Third anchor central part base portion 362c can also define third and recess 420, the third is kept to keep recess by pawl 414 rear side (that is, opposite, radially-outer surface of extension) and the base portion 410 of third anchor central part base portion 362c Proximal lateral limits.

Referring now to fig. 13, show anchor central part system 370, wherein the first anchor central part base portion 362a, Second anchor central part base portion 362b and third anchor central part base portion 362c are interconnected together.Such as description, the second anchor Determine device central part base portion 362b and third anchor central part base portion 362c is sized to and is configured to and the first anchor center Portion base portion 362a is interconnected to form anchor central part system 370.Second anchor central part base portion 362b and third anchor Central part base portion 362c can respectively be positioned as and be orientated with the first anchor central part base portion 362a into desired angle so that The direction of each central part base portion can be substantially corresponding with the direction of each in anchor portion (not shown).In addition, the The pawl 414 of three anchor central part base portion 362c, which is positioned to extend into, to be limited in the first anchor central part base portion 362a In first hole 394, and the protrusion 408 of the second anchor central part base portion 362b and pawl 414 and the first anchor central part The first hole 394 of base portion 362a is adjacent.In this manner, first, second, and third keeps recess 392,404,420 can be substantially right It is accurate so that band, line or other holding meanss (not shown) can be wrapped about to ensure the first, second, and third anchor center Each in portion base portion 362a-362c keeps interconnection, to maintain the assembling of anchor central part system 370.Such as description, the One anchor central part base portion 362a includes the first slit 396 being limited in its proximal part.First slit 396 can be determined Size is and is configured to be interconnected to the release cable being arranged in coil or pusher member (not shown) or tether (not shown), The release cable or tether are similar to previous reference Fig. 3 B and Fig. 8 A descriptions.As a result, when appropriate, it is anchored central part system 370 can together be discharged in company with other cables (being discussed in further detail below) being attached in the other parts of medical treatment device and Be conducive to release of the medical treatment device in LAA.

4A and Figure 14 B referring now to fig. 1 are respectively illustrated including anchor leg extension 360 and closer leg extension The sectional view of 328 central part system 308.For the sake of clarity, simply and anchor central part system is shown partially just System 370.In addition, the attachment of central part system 308 and conduit system has been not shown, but can be with previous with reference to Fig. 3 B and Fig. 8 A What is described is similar.

1A and Figure 14 A referring to Fig.1, central part system 308 or main central part system may include central part component 422, remote End cap 424 and one or more rings 426 etc..Central part component 422 may include that part (flared) 428 and remote is unfolded outside proximal end For end part 430 to limit hole 432, which, which has, extends through axis 325 therein.Distal end cap 424 may include close end 434 With funnel-like part 436.Close end 434 can be slided on the distal portions 430 of central part component 422 with central part component 422 interconnection so that each end in the hole 432 of central part system 308 has outer unfolded surface.In another embodiment, in The distal portion of center portion component 422 can outer expansion be with outer unfolded surface after the installation of ring 426, and by distal end cap 424 What is provided is similar.The processing will eliminate distal end cap 424 and welding.

The funnel-like part 436 of distal end cap 424 can be conducive to the anchor portion of anchor section as guide part (not shown) is easily interior by the pulling to anchor central part system 370 to be overturn or is pulled in conduit.Similarly, in Outside the proximal end of center portion component 422 deploying portion 428 be conducive to will to overturn outside the anchor portion (not shown) of anchor section or Release central part system 308.It is also contemplated by, the funnel-like part 436 of distal end cap 424 and/or the proximal end of central part component 422 Outer deploying portion 428 may include that can be limited to groove therein etc., be connected with the anchor portion with anchor section and It is corresponding, to be further used as guide part when anchor portion is drawn through or is forced through central part system 308 respectively Auxiliary maintains being accurately aimed at and preventing the overlapping between them substantially for they.As previously described embodiment, one Or remote end part in anchor frame section 350 can be arranged in multiple openings 429, (not for reversibly attachment release cable Show) or tether to be conducive to the release of medical treatment device.

The outer deploying portion 428 of central part component 422 can be sized to and be configured to setting to be limited to and anchor In the adjacent recess 368 in first outer end 356 of frame section 350 so that the anchor leg extension of anchor section 350 360 extend along the appearance of central part component 422 towards distal end.One or more rings 426 can be subsequently located at anchor leg On extension 360.As described in Figure 15, one or more rings 426 can be multiple in the inner surface 442 of ring with being limited to Recess 440, each recess 440 are sized to and are configured to receive corresponding anchor leg extension in a manner of being alternately arranged 360 (Figure 14 A) or closer leg extension 328 (Figure 14 B).By the arrangement, one or more rings 426 with recess 440 Can be used for that anchor section 350 and closer frame section 310 are remained to central part system with desired pattern or arrangement On 308.In addition, the outer surface of leg extension 360 and leg extension 328 (Figure 14 B) may include inclined-plane (not shown), the inclined-plane Be conducive to ring 426 to slide on leg extension 360 and 328 and 426 buckles of ring/locking is in place.

0A and Figure 14 B referring now to fig. 1 show that central part system 308 is attached to illustrate in central part system 308 Closer frame section 310.It is similar to leg extension 360 (Figure 14 A) of anchor frame section 350, closer frame section 310 can also include respectively closer base segments 326 and closer leg extension 328, and wherein closer base segments define Deploying portion 428 outside proximal end of the recess 332 to receive central part component 422, closer leg extension are trapped in one or more In the corresponding recess 440 (Figure 15) of a ring 426.Note that for convenience and clarity, showing that only one is closed in Figure 14 B Fill in the first half of the part and central part system 308 of device frame section 310.

Figure 16 is the stereogram of medical treatment device 300 (not having tissue growth component), it is illustrated that with closer frame section 310 and the central part system 308 that interconnects of anchor frame section 350, and one or more ring 426 be set as keeping closer and Each in anchor frame section 310 and 350.Additionally, it should be noted that closer frame section 310 and anchor frame Section 350 is in a manner of being alternately arranged around the setting of central part system 308 (that is, each closer frame section 310 is arranged at two Between anchor frame section 350 and vice versa).

Furthermore, it is noted that closer frame section 310 and anchor frame section 352 are separation and the list of medical treatment device 300 Only component.In addition, as in embodiment previous, the closer frame section 310 and anchor frame section 352 are discretely Deployment, wherein closer frame section 310 can dispose first so that doctor can be readily determined medical treatment device 300 in LAA Interior optimum position and direction, and be once positioned properly and orient, doctor can then pass through conduit (not shown) portion Anchor frame section 352 is affixed one's name to, as described about previously described embodiment.In addition, as in embodiment previous, Each in closer frame section and anchor frame section can be cut by laser by Nitinol plate, and cutting into has Structure and features for quickly assembling medical treatment device, and be conducive to convey by conduit system or medical apparatus system With the structure feature of release medical treatment device.It is, of course, also possible to use other manufacture materials and method.

7A and Figure 17 B referring to Fig.1 show the proximally and distally view of another embodiment 500 of medical treatment device.In the reality It applies in example, the frame structure of closer system 502 and anchor system 504 can be substantially similar to the preceding embodiment of explaination, But tissue growth component 506 may include other feature.For example, tissue growth component 506 can be further to distally prolonging It stretches so that tissue growth component 506 extends distal end similar with the distal end of the expanded configuration of anchor system 504 distance or degree Distance or degree.In addition, tissue growth component 506 may include between being limited in the distal portions of tissue growth component 506 Gap 512 or open section.The gap 512 can be the removed region in the part of tissue growth component 506.It is limited to tissue Gap 512 in growth component 506 can be positioned as and the anchor portion of anchor system 504 508 or anchor ring phase Corresponding or alignment.In this manner, when anchor system 504 expands in use state or expanding location, including arbitrarily engage Anchor portion 508 including component 510 or lug is by the tissue being biased against in LAA without tissue growth component 506 Material blockages anchor portion 508.In addition, the increased length of tissue growth component 506 (does not show the tissue abutted in LAA Go out) and the increased surface area being in contact with the tissue is provided.

In addition, one or more enhancing cables 514 may extend through the gap being limited in tissue growth component 506 512.Enhancing cable 514 can relative to extension anchor portion 508 it is substantially transverse or across extend.In one embodiment In, enhancing cable 514 can be the polymer filaments or cable being attached to using thermal process on tissue growth component 506.Pass through The anchor portion 508 of the arrangement, extension can abut or bias the inner surface of enhancing cable 514 and engagement member 510 extends Beyond enhancing cable 514 to be engaged with the tissue in LAA.In presently described embodiment, the line in gap 512 is extended through Cable 514 is spaced apart, and to help to ensure that engagement member 510 extends beyond enhancing cable 514, while also being provided for anchor portion 508 radial expansion is divided to limit (that is, limit how far can be radially extended when in deployable state about anchor portion System).The enhancing cable 514 can provide release mechanism to prevent for example when tissue is configured (remodeling) around implantation again The anchor portion 508 extended when occurring in the tissue of medical treatment device 500 extends too much at any time.

Figure 18 A and Figure 18 B are that the proximally and distally view of medical treatment device 500 according to another embodiment of the present invention (shines Phase), which, which has, is limited to the gap 512 into the tissue growth component 506 of elongate distal end and enhances cable 514 and extend through Cross the gap.In this embodiment, tissue growth component 506 may include multiple material layers.In one embodiment, tissue life The material layer of long component 506 may include one or more first layers 516 and one or more second layers 518.It is one or more First layer 516 may include foamed material, such as polyurethane foamed material, and one or more second layers 518 may include EPTFE, it is similar to those of described in the embodiment of front.

EPTFE may include multiple layers, such as two layers to four layers, or more.It has been observed that these ePTFE layers can be with Including different thickness and/or internode distance.Multiple ePTFE layers can be sized to substantially anti-Hemostatic Oral Liquid and thrombus across it In.EPTFE layers may be used thermal process or sintering process or other arbitrary techniques as known in the art such as pass through binder It is attached to each other.One or more ePTFE layers can be attached to sponge layer with adhesion.In one embodiment, it is set as The adhesion layer that ePTFE layers are attached on sponge layer is also filled up into the hole on the side of ePTFE, to further provide for base The tissue growth component that this anti-Hemostatic Oral Liquid and thrombus pass through.In addition, ePTFE in the proximal lateral of tissue growth component 506 Surface provide porous surface, the porous surface be easily conducive to blood cell aggregation and adhere to promote tissue growth and Thrombosis, this is because the surface is exposed to the surface of the atrium sinistrum (" LA ") of heart (not shown).

In another embodiment, as shown in figure 18, medical treatment device 500 may include central part tissue growth component 520.In this embodiment, central part tissue growth component 520 can be sized to and be configured in covering medical treatment device 500 The proximal lateral of center portion (referring to Figure 14 A and Figure 14 B).Such as description, pass through tissue growth component 506 and central part tissue growth structure Part 520 does not expose the frame structure of medical treatment device 500 substantially at the proximal end face of medical treatment device 500.This feature is advantageous, This is because when medical treatment device 500 is arranged in LAA, proximal end face is exposed to the surface of LA, thus substantially eliminates embolus Or the possibility that thrombus is fled to LA from LAA and/or shifted from exposed frame structure surface.In one embodiment, center Portion's tissue growth component 520 can be formed by multiple ePTFE layers and/or sponge layer, with the tissue growth structure previously illustrated Part 506 is similar.

Figure 19 is the partial cross-sectional view of anchor central part 522 (in simplified form), depicts and is attached in anchor Central part tissue growth component 520 in center portion 522.One embodiment of anchor central part previously 3 was described in detail referring to Fig.1 With show.Anchor central part 522 may include the appearance for being limited to central part (the one or more components for including central part) Recess 524 in face.Hole or eyelet 526 can also be formed in the close end of central part 522.Central part tissue growth component 520 may include distal portions 532 and the sock component with proximal end face 528.The proximal end face of central part tissue growth component 520 528 may include the pin hole 530 for being configured to be substantially aligned with the eyelet of anchor central part 522 526.Pin hole 530 is sized to And it is configured to make tether (being not shown in Figure 19) can extend through wherein for being removably attachable to anchor central part 522 eyelet 526.Central part tissue growth component 520 can be sized to and be configured to be assembled on anchor central part 522 To at least extend to the recess 524 of anchor central part 522.Central part tissue growth component 520 can for example by one or Multiple rings 534 or annular component (including spiral type ring) are attached to anchor central part 522, the one or more ring or cyclic annular structure Part, which can easily be extended on anchor central part 522 and be fixed on central part tissue growth component 520, to be formed in In recess 524 in anchor central part 522.In other embodiments, silk thread or filamentary members can give birth to around central part tissue Long component 520 winds and tightens in recess, and central part tissue growth component 520 is maintained at anchor central part 522 On.Central part tissue growth component 520 can also be maintained at desired position using other devices.Pass through the arrangement, anchoring Device central part 522, and it is prior, and the proximal end face 528 of anchor central part 522 can be covered with central part tissue growth structure Part 520, so that the surface for being exposed to LA is optimized for endothelialization and prevents embolus or thrombus from turning between LAA and LA It moves.

In another embodiment, medical treatment device may include dissolving component 550, and it is limited which is configured to provide for one Period, in the limited period, the ring part 554 of the anchor section 552 in anchor system is biased against Tissue or offer in LAA (not shown) are extended to the outside with against the tissue in LAA.For example, Figure 20 depict in anchor The dissolving component 550 that center portion base portion 556 interconnects.For simplicity, only one anchor section 552 is shown as having dissolving Component 550.The dissolving component 550 can be made of bioabsorbable material, but can also by bioresorbable material or Biodegradable material or combination thereof are made.Such as description, dissolving component 550 can be around anchor central part base portion 556 Circumferentially it is arranged and is set as adjacent with the distal end of the anchor central part base portion so that the ring of another anchor section 554 Circle part 554 is biased by the dissolving component 550 adjacent with the proximal end inner end 572 of ring part 554, or can be by the dissolving Member supporting or against the dissolving component.

By the embodiment, tissue when being implanted in LAA and in closer system (not shown) and LAA into In the sufficiently long time of row endothelialization, anchor system can be held as being similar to described in embodiment previous Row function and operation.After the predetermined time period, dissolving component 550 is degraded or is dissolved into body so that dissolving component 550 No longer it is the component of medical treatment device.It no longer exists as a result, cannot provide the loop portions to anchor section previously provided Divide 554 bearing.The ring part 554 of anchor section 552 will not provide the identical biasing against the tissue of LAA as a result, Power, but will fold or curve inwardly due to the structure feature in the anchor central part base portion 556 that is described below (or Displacement).

Figure 20 A are the amplifications such as the dissolving component 550 being connected on anchor central part base portion 556 described in Figure 20 Figure.Dissolving component 550 may, for example, be circle tube member, or other arbitrary suitable shapes, is sized to and is configured to It slides on distal center portion extension 560 or is slided around distal end central part extension.Distal center portion extension 560 can be from One in the anchor central part base portion 556 of anchor section 552 extends to distal end and at center.In addition, distal center portion Extension 560 may include the middle section 562 and widened distal portions 564 of recess.The middle section 562 of recess can be determined Size is and is configured to receive dissolving component 550, and widened distal portions 564 can be sized to and be configured to prevent from dissolving Component 550 is detached with distal center portion extension 560 or is shifted certainly.

Such as description, ring part 554 be set as dissolving component 550 outer surface 566 against dissolving component 550 or by The dissolving member supporting.The proximal end inner end 572 of ring part 554 is with anchor central part base portion 556 by being arranged at them Between thinner extension 570 interconnect.The thin extension 570 can be sized to and be configured to：Once dissolving component 550 Have already dissolved into body and be advantageous for the contraction of ring part 554, with this come limit ring part 554 against LAA tissue Outward force.In other words, it once dissolving component 550 has dissolved, is then configured to opposite without supporting and flexible thin Extension 570 will not provide for making ring 554 keep being biased against enough bearings of tissue, thus make ring part 554 can shrink (or radially-inwardly shifting).In this manner, the combination of dissolving component 550 and thin extension 570 is as follows Device：By the device, medical treatment device can be anchored in LAA, and dissolving component 550 dissolve predetermined amount of time it Afterwards, the ring part 554 of anchoring system can shrink or become being easy flexible (limp) relative to the tissue in LAA.As above It states, dissolving component can be designed as dissolving within the desired period.For example, dissolving component 550 can be configured such that its Dissolved in the about the same period occurred with expected endothelialization, or with percentage that desired endothelialization will occur Number measures dissolving in the relevant period.

Referring now to Fig. 21, show medical device delivery system 600 according to another embodiment of the present invention.Medical treatment dress It may include medical treatment device 602, sheath 604 and the conduit system 608 being connected in steerable system 610 to set transport system 600.For Reference, axis 601 are limited to extend through medical device delivery system 600.Medical treatment device 602 may include being configured to intervene Formula is implanted to any of arbitrary medical treatment device, including medical devices described herein in organization of human body or their group It closes, such as the medical treatment device that embodiment description will be combined.Sheath 604 can define the slender member of sheath lumen 606, The sheath lumen extends axially through between the close end and distal portion of sheath 604.Sheath can be individual, independent structure Part (not being to be permanently coupled to transport system) is sized to and is configured to the 606 reception conduit system of lumen by sheath 604 System 608.It is also contemplated by, sheath 604 is combined with the sheath being separated with the steerable system 610 being described in conjunction with the present embodiment Steerable system, the sheath steerable system can be structured as making the distal portions of sheath to pivot.

With reference to Figure 21 and Figure 21 C, conduit system 608 may include conduit 622, such as the slender conduit or structure of extrusion forming Part has multiple lumens that axially length extends between the distal portion and close end of conduit 622.For example, multiple lumens May include center lumen 624 and one or more peripheral lumens 626, such as two peripheral lumens shown in Figure 21 C.Separately Outside, conduit system 608 may include extending through the more tethers for limiting multiple lumens in the catheter, and tether is in medical treatment device Extend between 602 and steerable system 610 and makes to interconnect between medical treatment device and steerable system.

For example, conduit system 608 may include one or more closer tethers 628 and one or more anchor tethers 630.Center lumen 624 can be sized to and be configured to receive anchor tether 630, and one or more peripheral lumens 626 It can be sized to and be configured to receive closer tether 628.Anchor tether 630 may include anchor pusher 632, than Such as coil or the component of other generally tubulars, wherein anchor pusher 632, which defines, extends longitudinally through anchor therein Pusher lumen 634 and more lines for extending through anchor pusher lumen 634.Similarly, closer tether 628 can wrap Closer pusher 636, such as the component of coil or other generally tubulars are included, defines and extends longitudinally through closer therein Pusher lumen 638 and more lines for extending through closer pusher lumen 638.Anchor pusher 632 and closer push away Each in dynamic device 636 may include the polymeric layer formed around it.

Closer tether 628 and anchor tether 630 can be connected to medical treatment device 602 via more lines, the more lines Extend through corresponding closer pusher 636 and anchor pusher 632 and extend in steerable system 610 and with the behaviour Vertical system interconnection.The distal portion of each in closer pusher 636 and anchor pusher 632 may be directly connected to To medical treatment device 602.More lines may include such as First Line 640 and the second line 642, First Line 640 be pulls wire and second Line 642 is pin line.First Line 640 and the second line 642 work and can be conducive to the interconnection and release of medical treatment device 602, As being discussed in further detail herein.By the arrangement, conduit system 608 is it is so structured that passing through the vascular of patient and leading to Sheath 604 is crossed to push medical treatment device 602 to LAA and be conducive to distal portions via steerable system 610 in conduit system 608 Medical treatment device 602 is operated and controlled at 621.The operation and control of medical treatment device 602 may include isolating and independently controlling Various functions, including the deployment function of the anchor portion 603 (Figure 21 A) of such as medical treatment device 602 and closer part 605, Best orientation and repositioning of the medical treatment device 602 in LAA, the disposing and curing again after complete anchoring device in LAA Treatment device removes medical treatment device 602 after the complete anchoring in LAA from LAA.

Referring back to Figure 21, steerable system 610 may include one or more actuating elements, such as closer actuating element 612, anchor actuating element 614 and floating actuating element 616, each of which can be used for implementing different functions Medical treatment device 602 is controlled and operated at the distal portions 621 of conduit system 608.For example, when steerable system 610 is in the When in one actuated position, by retraction sheath 604, closer part 605 can be disposed.As described in Figure 21 and Figure 21 A, By making anchor actuating element 614 move forward to the second actuated position (as described as arrow 618), medical treatment device 602 Anchor portion 603 can be by making to overturn outside one or more anchors or distal movement is to producing position or anchor Deployed position and disposed.Moreover, as described in Figure 21 and Figure 21 B, by making 616 proximal movement of floating actuating element (as described as arrow 620) to third actuated position, conduit 622 can also retract is connected to medical treatment device with exposure and deployment Closer tether 628 on 602 and anchor tether 630, can determine whether medical treatment device 602 is correctly sat in LAA It leans on and is arranged.

With reference to Figure 21, Figure 23 and Figure 24, the more detailed description to steerable system 610 will be provided now.Figure 23 and Figure 24 are Along the sectional view for the steerable system 610 that the section line 23 and 24 in Figure 22 intercepts, Figure 22 illustrates the proximal end of steerable system 610 The end-view of side.Since the distal side of steerable system 610, floating actuating element 616 may include outer housing 644, the shell Body defines the hole 646 that outer housing 644 is extended axially through between the distal portion and close end of outer housing.Conduit 622 it is close End could be attached to the distal portion of outer housing 644, such as by being inserted and fixed in the hole 646 of floating actuating element 616. The close end of floating actuating element 616 can be slidably coupled to the interior extension 652 of closer actuating element 612, inside prolong Extending portion 652 is sized to and is configured to the sliding in the hole of floating actuating element 616 646.Floating actuating element 616 can be limited The linear movement being formed on interior extension 652, such as the ditch by means of being limited in the inner surface (in hole) of outer housing 644 Interaction between slot 648 and the guide part 654 formed on interior extension 652.The outer housing of floating actuating element 616 644 can also be attached to floating lever 650, which proximally extends from floating actuating element 616 and extend through occlusion Device actuating element 612, as will be discussed in greater detail below.By the arrangement, floating actuating element 616 can be grasped in closer It is linearly slided on the interior extension 652 of vertical part 612.Since the close end of conduit 622 is fixed on floating actuating element 616 In hole 646, the movement proximally of floating actuating element 616 will make the conduit of conduit system 608 (as indicated as arrow 620) 622 retract, and thus allow the floating feature for medical treatment device 602, as previously discussed.

With reference to Figure 24 A, the enlarged drawing of a part for the floating actuating element obtained from the details " 24A " of Figure 24 is shown. In order to maintained when making floating 616 proximal movement of actuating element closer pusher 636 with extend through conduit system 608 and The globality of the association line (being not shown in Figure 24 A) of steerable system 610, pipe fitting 653 (such as hypotube (hypo-tube)) can be with Fixation coaxial with the multiple lumens being formed in interior extension 652, multiple lumen again with the periphery chamber that is limited in conduit 622 626 coaxial correspondence of pipe and slideably extend (referring to Figure 21) towards the peripheral lumens.The chamber being limited in interior extension 652 Pipe may include conduit portion corresponding with the configuration of conduit 622, or may include that setting is being defined in interior extension 652 In hole in associated housing parts.In this manner, when floating 616 proximal movement of actuating element, closer pusher (coil) and line maintain the position stretched substantially when conduit 622 is retracted.During the proximal movement of conduit 622, pipe fitting 653 It can be fixed in interior extension 652 and be slided in the peripheral lumens 626 in the close end for being defined in conduit 622.Pipe fitting Thus 653 arrangement can prevent line substantially in floating actuating element 616 towards during the movement proximally of inwardly-extending portion 652 The flexure of circle and line.

Referring back to Figure 23 and Figure 24, the middle section of closer actuating element 612 or steerable system 610 can wrap Include outer housing 658, the interior extension 652 indicated above and closer release slider 660.Outer housing 658 can define outside Axially extending hole 662 between the close end and distal end of shell 658.The outer housing 658 can be sized to and be configured to house Interior extension 652, closer release slider 660 and mode switch 664.Mode switch 664 can pass through pattern supporting structure 666 It is fixed at close end in outer housing 658.

Interior extension 652 can extend axially through the hole 662 of outer housing 658, be attached to pattern at one end Supporting structure 666.The outer housing 658 of the other end of interior extension 652 from closer actuating element 612 is axial and to distally prolonging It stretches and a part that is slidably coupled with floating actuating element 616 and extending through floating actuating element.Interior extension 652 may also extend through the slider bore 661 being limited in closer release slider 660.In the position of description, closer is released It puts sliding block 660 and is fixed to interior extension 652 via the arrangement of recess 668 and spring-loaded pawl 670 so that pawl 670 can To be moved from the recess 668 being limited in interior extension 652 so that closer release slider 660 being capable of proximal movement, such as general It discusses in further detail below.Spring-loaded pawl 670 it is so structured that such as part annular clip, can be around closing It fills in device release slider 660 to be arranged, wherein pawl 670 extends through hole in closer release slider 660 or slit 672 simultaneously And it further extends into the recess 668 of interior extension 652.

The closer being connected on closer tether line (shown in dotted line) is depicted with reference to Figure 24 and Figure 24 B, Figure 24 B to release Put the amplifier section of sliding block 660.In one embodiment, closer release slider 660 can be defined relative to medical treatment device The axis 601 of transport system 600 is laterally extended and can be axially aligned with one another two holes 674.In addition, closer release is slided Block 660 can define the main line 676 being formed in the outer surface of closer release slider 660, which is sized to And it is configured to closer tether line being fixed thereon.Moreover, interior extension 652 can define substantially in interior extension 652 Hole and the outer surface of interior extension 652 between extend two opposite notch types openings 678.Notch type opening 678 it is close End can extend to the hole 674 of closer release slider 660 and corresponding with the hole.The distal portion of notch type opening 678 Extend to the longitudinal guide groove 680 being defined in the inner surface of closer release slider 660.

In one embodiment, two groups of closer tether lines are equipped with.As previously illustrated, every group of closer tether line To include First Line 640 and the second line 642, First Line 640 is pulls wire and the second line 642 is pin line (referring also to Figure 21 C). For one group of closer tether line, First Line 640 can from periphery lumen 626, pass through a notch type of interior extension 652 Opening 678, along the guide groove 680 being limited in closer release slider 660, around the distal end of closer release slider 660 Portion and towards main line 676 extend, with circumferentially wind around groove 676 and fixation in the trench.Second line 642 or pin Line can also be by the notch type of interior extension 652 opening 678, through hole 674 and around the appearance of closer release slider 660 Face extends, and extends in main line 676 to wind groove and fix in the trench.Such as description, another group of closer Tether line can be by extend through the interior extension 652 on the opposite side of closer release slider 660 and around occlusion The main line 676 of device release slider 660 winds and is similarly fixed to closer release slider.It is further noted that anchor system 630 (shown in dotted line) of rope extend axially through closer actuating element 612 towards anchor actuating element 614.

With reference to Figure 23 and Figure 23 A, mode switch 664 will be discussed now.As previously illustrated, closer actuating element 612 Can include at its proximal end mode switch 664 at side.Mode switch 664 may include can be for example in first position and second The switch moved between setting.Mode switch 664 can be fixed to closer actuating element 612 via pattern supporting structure 666.Example Such as, such as best depiction in fig. 24, pattern supporting structure 666 may include the close end of interior extension 652 or be fixed to outer Interior discoid component 667 on discoid component 669, wherein 664 ground of mode switch at least part are clamped in the outer discoid component Between the interior discoid component.Interior discoid component 667 can be sized to closely (snugly) be assembled in outer housing 658, And outer discoid component 669 is sized to the close end of the outer housing 658 of capping closer actuating element 612.Interior extension 652 Close end can be fixed to interior discoid component 667.The configuration can be used for mode switch 664 being sufficiently remained in position and have Multiple positions are moved to conducive to by mode switch 664.

Referring again to Figure 23 and Figure 23 A, mode switch 664 may include being defined in one or more of keyholes, than Such as the first keyhole 682, the second keyhole 684 and third keyhole 686.Each in one or more keyholes 682,684 and 686 can It is corresponding with the different piece of steerable system 610 to be sized to and be configured to, for example, respectively with release lever 688, anchor bar 690 and floating lever 650 it is corresponding.Each in these bars can be right with them as the position relative to mode switch 664 The key for the keyhole answered.Release lever 688 and anchor bar 690 are fixed to anchor actuating element 614 and extend from it to distal end, To extend through one or more keyholes and enter in closer actuating element 612.Release lever 688 and anchor bar 690 Closer actuating element 612 can be selectively slid through relative to mode switch 664.For example, the first keyhole 682 can be determined Size is and is configured to receive the planarization section of release lever 688 so that release lever 688 can be based on the position of mode switch 664 And (or rotation) is slided to different positions.Similarly, the second keyhole 684 can be sized to and be configured to receive anchor bar 690, it can be slid through wherein based on the position of mode switch 664.Similarly, third keyhole 686 can be sized to and structure Make for receive floating lever 650 so that floating lever 650 can the relative position based on mode switch 664 and slideably shift logical It crosses wherein.The other details about mode switch 664, its positioning and control is discussed further below and it is filled for medical treatment The functionality (Figure 21) of the offer of transport system 600 is provided.

Referring back to Figure 21, Figure 23 and Figure 24, anchor actuating element 614 may include outer housing 692, anchor manipulation Fixing component 694 and anchor release slider 696, each defines axially extending stepped hole wherein.In addition, anchor Actuating element 614 may include that switch 698 is allowed in the release being arranged at portion at its proximal end (referring also to Figure 22).Anchor manoeuvre portion Divide 614 each structure member can be arranged in many ways relative to each other.For example, anchor manipulation fixing component 694 can To be fixed to anchor bar 690 so that anchor bar 690 hermetically extends through the distal end that anchor manipulates fixing component 694 Portion and enter be defined in anchor manipulate fixing component 694 in hole large scale part in.Anchor release slider 696 can be with It is arranged on the close end of anchor bar 690 and is arranged the proximal end in the hole in being defined in anchor and manipulating fixing component 694 In side.

The proximal lateral of outer housing 692 can be arranged manipulates fixing component 694 and anchor release slider 696 in anchor On, and fluid port 702 extends axially through the proximal lateral of outer housing 692 and by the close of anchor release slider 696 End part is conducive to fluid communication by steerable system 610 and to conduit system 608 to be interconnected with anchor bar 690. One or more sealing rings 704 can be used for the interconnection of the sealing between fluid port 702 and anchor bar 690.In addition, anchor It includes the longitudinal extending bore for manipulating the longitudinal axis of fixing component 694 with anchor and deviateing to manipulate fixing component 694, which prolongs Stretching hole can be sized to and be configured to receive release lever 688.Release lever 688 can linearly be fixed to outer housing 692 and It is selectively rotated relative to outer housing, to extend through anchor manipulation fixing component 694 and extend through occlusion Device actuating element 612.By the arrangement, outer housing 692 and anchor release slider 696 can be fixed to one another.In addition, anchor Fixing component 694 and outer housing 692 can be fixed in the position of description.But once anchor actuating element 614 is to distally It moves to closer actuating element 612 and mode switch 664 moves to the position of " anchor locking-floating is allowed ", so that it may Allow switch 698 with actuating release or release is made to allow switch rotary, this can make anchor release slider 696, outer housing 692 It is slideably moved relative to anchor fixing component 694 with each in release lever 688, medical treatment such as will be discussed in detail below As being described in more detail when the release of device.

With reference to Figure 24 C, the enlarged drawing of the anchor actuating element 614 obtained from the details " 24C " of Figure 24 is shown, describe Anchor actuating element 614 with the interconnection (shown in dotted line) of anchor tether line.Anchor tether line can axially prolong Extend through anchor bar 690 and by a part for anchor actuating element 614.It is similar to closer tether line, anchor Tether line may include First Line 640 and the second line 642, and First Line 640 is pulls wire and the second line 642 is pin line.First Line 640 is it is so structured that leave anchor bar 690 and in the outer surface of anchor 690 and anchor release slider 696 Extend between surface.First Line 640 can also around anchor release slider 696 distal portion and along anchor release slider 696 outer surface extends.Such as description, it can be equipped with and decline along the longitudinal length of the outer surface of anchor release slider 696 Groove for First Line 640 along its extend.The groove of decline, which can extend to, is formed in anchor release slider 696 Radial groove 706 in proximal part.First Line 640 can extend to radial groove 706 and around 706 circumferential direction of groove as a result, Ground winds and is fixed in groove 706.For the second line 642, which can be from anchor bar 690 axially The hole 708 for extending through anchor release slider 696, extends through on the close end of anchor release slider 696 and is formed in Groove and entrance in the proximal part of anchor release slider 696 are formed in the radial groove 706 in proximal part, with It winds the radial groove 706 of anchor release slider 696 and is fixed in the radial groove 706.By the arrangement, when In LAA (being not shown in Figure 24 C) when release medical treatment device, anchor release slider 696 can with proximal movement, thus due to around Anchor release slider 696 wind First Line relaxation and pull the second line 642 before pulling First Line 640.Hereinafter The relevant other details of release with tether line will be provided.

5 and Figure 25 A referring now to Fig. 2 show steerable system 610, depict and are distally advanced to the second actuated position Anchor actuating element 614, the second position is associated with the anchor deployed position of medical treatment device 602.Notice Figure 25 It is sectional view identical with Figure 23, but in the second actuated position.In anchor deployed position, anchor actuating element 614 can move to abut closer actuating element 612.By the movement, anchor bar 690 and the also direction of release lever 688 are closed Fill in device actuating element 612 and the identical linear range of distal movement in closer actuating element 612.It is connected to due to coaxial Together, the movement towards distal direction of anchor bar 690 also makes anchor tether 630 (Figure 21 C) travel forward substantially similar Distance to dispose the anchor portion 603 of medical treatment device 602 (see, e.g. Figure 21 A).The proximally facing side of release lever 688 To movement by being defined in release in closer release slider 660 and adjacent with the pawl of closer release slider 660 670 Rod aperture 712 (Figure 34 A) and the abutting edge 710 (Figure 34 B) that release lever 688 is set.

Mode switch 664, which is placed in first position, allows anchor actuating element 614 to move, and thus allows medical treatment device Anchor portion movement.It is opened by the pattern in the first position such as described in Figure 25 and Figure 25 A or " lower position " It closes, anchor actuating element 614 can freely move between anchor deployed position and anchor retracted position.It is this right The control of deployment and the retraction independently of other component such as closer of anchor is conducive to doctor and obtains medical treatment device in LAA Interior optimal placement and positioning.

With reference to Figure 26 and Figure 26 A, steerable system 610 is shown, depict floating actuating element 616 be proximally retracted into The associated third actuated position of tether deployed position for medical treatment device 602.In order to move to third actuated position, As described in Figure 26 and Figure 26 A, mode switch 664 from first position (above description) move to the second position or " upward position ".This move upwards change keyhole in the configuration of each, or change respectively with release lever 688, anchor At least part of configuration of 650 corresponding keyhole of bar 690 and floating lever.In addition, as previously illustrated, release lever 688, anchor It includes being somebody's turn to do along the key-like configuration of the part of the selection of their corresponding length to determine each in device bar 690 and floating lever 650 Key-like configuration can be used as key.These key sections are beneficial to the cause to anchor actuating element 614, floating actuating element 616 Move or prevent it from activating or being conducive to allow release the actuating of switch 698.

For example, by the mode switch 664 in the second position, the actuating of anchor actuating element 614 can pass through Engagement (Figure 24) with the anchor bar recess 714 being defined in anchor bar 690 and be prevented from.For example, when anchor manipulates When part 614 has moved and mode switch 664 is placed in the second position, the narrow and anchor of the second keyhole 684 The anchor bar recess 714 of bar 690 engages, and thus prevents anchor actuating element 614 from further moving.Similarly, it floats Bar 650 can also define floating lever recess 716 (Figure 23), and the floating lever recess is corresponding with third keyhole 686 and constructs To prevent the movement of actuating element 616 until anchor actuating element 614 moves to the second actuated position and mode switch 664 is transported It moves until the second position.In addition, when mode switch 664 is in the second position, key enables release lever 688 to rotate fortune It is dynamic, and when in first position, key prevents 688 rotary motion of release lever.More specifically, the first keyhole 682 includes square shape Or rectangle part 718, the part 718 when mode switch 664 is in first position (referring to Figure 25 A) with 688 phase of release lever It corresponds to prevent rotary motion.But when mode switch 664 is placed in the second position, the first keyhole 682 includes circular portion 720, the circular portion is corresponding with release lever 688 to allow rotary motion (referring also to Figure 25 A).

By the mode switch 664 in the second position, floating actuating element 616 can proximally and axially retract The distance of restriction.For example, floating actuating element 616 can shift until it is positioned against closer actuating element 612. By the proximal movement, floating lever 650 is gone back in proximal movement a to part for anchor actuating element 614.In addition, floating The proximal movement of actuating element 616 makes 622 proximal movement of conduit, this is because the close end of conduit 622 is fixed to floating Actuating element 616.In this manner, tether such as closer tether 628 and anchor tether 630 maintain their axial position simultaneously And (referring to Figure 21 B) is disposed by conduit 622, it thus limits and is acted on the medical treatment device of implantation by the transport system being still attached Resistance or bias force.It if desired, can be only by making 616 distal movement of floating actuating element to its previous position that will be Rope is reloaded into conduit 622.In addition, if desired, can only by make mode switch 664 move back into first position and then Make the anchor portion of 614 proximal movement of anchor actuating element and retraction medical treatment device.

With reference to Figure 27-Figure 29, steerable system 610 be shown at releasing position with by medical treatment device 602 from transport system It is discharged in 600.In figure 27 best seen from (when being compared with unreleased position shown in Figure 22), release allow out It closes 698 and moves to releasing position, wherein release allows switch 698 that can allow to switch pivot 722 around release with clockwise side Formula rotates.In addition, release allows switch 698 that can define radial opening 724, which extends release and allows to switch 698 movements are to be placed in the distance in releasing position.Fluid port 702, which proximally extends through, to be defined in release and allows to switch Radial opening 724 in 698.

The sectional view for the steerable system 610 that Figure 28 and Figure 29 is intercepted respectively along the section line 28 and 29 of Figure 27, describes Some components of steerable system 610 in releasing position.It is noted that for convenience and clarity, anchor is not shown Determine the outer housing 692 (Figure 23) of device actuating element 614.But it is further noted that as the outer housing previously illustrated is fixed to anchor Determine device release slider 696 and thus outer housing can be when anchor release slider 696 moves to releasing position and anchor Release slider 696 moves together.

In releasing position, release lever 688 is proximally retracted.In one embodiment, the retraction of release lever 688 also makes anchor Determine 660 proximal movement of device release slider 696 and closer release slider, but retains or anchor is maintained to manipulate fixing component 694 against closer actuating element 612.It is noted that the pawl 670 of closer release slider 660 is from interior extension component 652 Recess 668 moves, and closer release slider 660 is thus enable to move to releasing position by release lever 688, such as will be with reference to figure As 34- Figure 35 is shown in further detail and describes.In this manner, 696 energy of closer release slider 660 and anchor release slider Enough proximal movements in a manner of synchronization arrangement.

It is every in closer tether 628 and anchor tether 630 with reference to Figure 24 B, Figure 24 C and Figure 28 as previously illustrated One First Line 640 and the second line 642 are fixed to corresponding closer release slider 660 and anchor release slider 696.Tool Body, the First Line 640 of closer tether 628 and anchor tether 630 can be around corresponding closer release slider 660 and anchor The proximal part of device release slider 696 is determined to distal end winding and then to proximal wind.In addition, closer tether 628 and anchor Corresponding closer release slider 660 and anchor release slider can be extended proximally by determining the second line 642 of device tether 630 696.In this manner, once closer release slider 660 and anchor release slider 696 are proximally retracted, the second line 642 it is remote End is just by the relaxation distance 726 that is provided from the winding proximally of First Line 640 and in 640 distal portion of First Line to close It is proximally shifted before the displacement of end.In other words, First Line 640 not along its length proximal movement until relaxation distance 726 Until being overcome by closer release slider 660 and anchor release slider 696 distance that proximal movement has been moved.At this In embodiment, slide block movement is that corresponding closer sliding block 660 and anchor are discharged to overcome the distance of loose distance 726 The relaxation distance 726 of sliding block 696 approximately twice as.By the arrangement, as described in Figure 39, the second line 642 can be first Such as it is pulled with indicating by arrow 732, to be formed from the First Line 640 of the eyelet 730 by extending through medical treatment device 602 Ring 728 moves, and the distance 726 (Figure 24 B and Figure 24 C) that once relaxes is overcome, and just pulls First Line 640 from eyelet 730, To release loose closer tether 628 and anchor tether 630 from medical treatment device 602.

As described in Figure 26 A and Figure 28 A, mode switch 664 is in the second position or upward position.Mode switch 664 second position enables the rotation in the circular portion 720 of the first keyhole 682 of release lever 688, mode switch 664 to the The movement of two positions can be used at any moment after the anchor portion of medical treatment device 602 is disposed.In other words, it is Mode switch 664 moved to the second position allows switch 698 can rotate or activate release, it is not necessary to using by making to float The floating feature that formula actuating element 616 is retracted.In this manner, the movement and/or release of floating actuating element 616 allow to switch 698 movement (can be described by the mode switch 664 in the second position or upward position in such as Figure 26 A and Figure 28 A ) implemented.

Referring now to Figure 30-Figure 33, now will with the relevant other details of the release characteristic of anchor actuating element 614 It is discussed.It is noted that in order to be clearly shown that the various parts and feature of anchor actuating element, Figure 31-Figure 33 are not shown Go out the outer housing 692 of anchor actuating element 614.Figure 30 shows the section line " 30 " along Figure 22 intercepts, anchor behaviour The amplification section of the distal portions of vertical part 614, and the release being depicted in first position or unreleased position is allowed Switch 698.The outer housing 692 of anchor actuating element 614 can define cavity 734 wherein.Cavity 734, which can have, to be set The spring loaded pin 736 being placed in one.When release allows switch 698 to be in first position, spring loaded pin 736 may be at Restriction site (that is, as shown in Figure 30).In addition, when release allows switch 698 to be in first position, release lever 688 Release lever protrusion 738 is arranged in the ancon groove 740 in being defined in anchor and manipulating fixing component 694, such as in Figure 31 Describe.In this manner, anchor fixing component 694 can be operably coupled to or be fixed to anchor release slider 696 And it is attached directly to release lever 688.

As described in Figure 32 and Figure 33, once release allows switch 698 to rotate to the second position (best institute in Figure 27 The second position shown), spring loaded pin 736 is moved to or springing allows exposure recess portion in switch 698 to release is defined in 742, which can allow release switch 698 irreversibly to fix in the second position.Moreover, when release is allowed out When closing 698 rotations to the second position, release lever 688 also rotates, and thus makes the release lever protrusion 738 extended from release lever 688 Relative to the rotation of anchor fixing component 694 to disengaged position.As described in fig. 33, by by release lever protrusion 738 It is set as allowing a part, that is, anchor release slider 696 of linear movement, release lever 688 and anchor actuating element 614 It can be retracted with proximally facing dimension linear with outer housing (not shown).

Referring now to Figure 34, Figure 34 A, Figure 34 B and Figure 35, the release of the movement for implementing closer release slider 660 The other description of bar 688 will be provided now.Again, the shell of closer actuating element is for the sake of clarity not shown Body.It is configured as key with reference to Figure 34, Figure 34 A and Figure 34 B, release lever 688, defines the work(of auxiliary control steerable system 610 Multiple structure features of energy property.For example, release lever 688 can be elongated narrow on the distal portions of release lever 688 with being limited to Narrow portion 744, the elongated and narrow part are sized to and are configured to below the pawl 670 of closer release slider 660 sliding It moves or linearly moves.Elongated and narrow part 744 can be by removing upper elongated portion approximately half of or three of release lever 688 / bis- and formed so that when release lever 688 as describe be oriented in first position when, elongated and narrow part 744 is orientated It is easily slided below pawl 670 when distal movement.Such as the best depiction in Figure 34 B, elongated and narrow part 744 Close end may include being defined in release lever recess 746 therein.Release lever recess 746 can be sized to and be configured to catch Obtain or be attached to closer release slider 660 so that release lever 688 can make closer release slider 660 retract.

As described in Figure 35 and Figure 35 A, mode switch 664 moves to the second position or upward position.As previously explained It releases, the rotary motion of release lever 688 is allowed in the second position of mode switch 664.As shown in Figure 35 and Figure 35 A, discharge Bar 688 is in rotation position.But before the movement of the rotation of release lever 688 and mode switch 664 to the second position, Release lever 688 travels forward to dispose the anchor portion of medical treatment device 602.In rotation position, release lever 688 is via release lever Release lever recess 746 (Figure 34 B) in 688 can capture closer release slider 660.In addition, in rotation position, pawl 670 Moved upwards via the rotation, pawl 670 movement and it is recessed in the interior extension 652 of closer actuating element 612 with being defined in Mouth 668 detaches, and so that closer release slider 660 is disconnected with interior extension 652 and couples.The proximal movement of release lever 688 It is then able to that closer release slider 660 is made proximally to retract so that closer release slider 660 is adjacent with mode switch 664. As previously illustrated, the proximal movement of release lever 688 makes closer release slider 660 and the (figure of anchor release slider 696 It is not shown in 35 and Figure 35 A) it retracts at the same time for making closer tether and anchor tether and medical treatment device substantially same time-division It opens.

Referring now to Figure 36-Figure 40, show according to another embodiment of the present invention, with medical delivery device (for example, Conveying device 600 in Figure 21) sectional view of medical treatment device 602 that is connected.Medical treatment device 602 includes 605 He of closer part Anchor portion 603.The medical treatment device 602 described herein is similar to the medical treatment device described in Fig. 9 A and Fig. 9 B, and there are three tools Anchor section (there are six anchor rings 748 (two anchor rings 748 of each anchor section) for tool) and six occlusions Device frame section 750 is each positioned as and is orientated in an alternating fashion around central part 752.For simplicity, in Figure 36- Sectional view in Figure 40, which depicts, works as rotation to the anchor ring 748 and closer frame section 750 in same level, although In this embodiment, they can be orientated in such a way that illustrates in the aforementioned embodiment is alternately arranged around central part 752.

The description for illustrating medical treatment device 602 relative to the various positions of medical device delivery system is seen now.It will cure It treats device 602 to be introduced to before LAA (being not shown in Figure 36-Figure 40), sheath 604 can be first introduced into LAA.In this field Those of ordinary skill known to, sheath can be introduced into towards heart atrium dextrum extend and extend to the vascular in atrium dextrum It is interior.For example, can be realized by femoral vein to approaching in atrium dextrum.Sheath 604 can then be drawn via diaphragm puncture Enter in atrium sinistrum, and be subsequently located in LAA, it is preferable that in this embodiment, by sheath at deeper rear positions Distal portion is arranged in LAA, is positioned and is arranged by conventional operation and imaging technique.

As described in Figure 36, once sheath 604 be arranged in LAA, so that it may with by sheath 604 in sheath 604 At close end medical treatment device 602 is pushed initially towards LAA.Medical treatment device 602 can be via the loader being arranged around conduit 622 754 are introduced into (referring to Figure 21) in sheath 604.Loader 754 can move to the distal portion 758 of conduit 622 against deployment Closer part 605, and pulled in loader 754.The end of loader 754 can be subsequently inserted into sheath 604 In close end so that conduit 622 can manually advance through sheath 604, and medical treatment device 602 is thus made to advance to sheath 604 Distal portions and enter LAA in.Such as description, advanced by the distal portion of conduit 622 towards sheath 604, medical treatment The anchor portion 603 of device 602 be retracted into the distal portions 756 of conduit 622 and closer part 605 relative to conduit 622 distal portion 758 is distally arranged.Once medical treatment device 602 is arranged at the distal portions of sheath 604 in LAA, then The sheath 604 that can manually retract (as described as arrow 760) deployment closer part 605, this is conducive to dispose The closer part 605 of medical treatment device 602.

As described in Figure 37, sheath 604 is in retracted position and closer part 603 is in deployed position. Since closer frame section 750 is from extension feature, which can be by making sheath 604 retract by certainly It disposes dynamicly.In this embodiment, closer part 605 can not have any anchoring function, but as previously described, packet Including tissue growth promotes component 762, the tissue growth that component is promoted to have provide soft and submissive closer part 605 one A or multiple layers.By imaging technique, doctor can slowly pull medical treatment from the rear positions in LAA towards desired position The closer part 605 of device 602 stops and analyzes multiple and different position and direction in LAA until determining most preferably Or preferred position until, such as it is adjacent with aperture and in LAA.If doctor believes closer part at any time 605 have been pulled out the arteries and veins mouth position in LAA or are pulled out from LAA, and doctor can be only by making 604 distal movement of sheath And closer part 605 is easily captured again.Sheath 604 is then able in LAA depth again and advances to ground, and closer portion 605 are divided to be disposed again and be then retracted to the optimum position for closer part 605 to be placed.Once optimum position exists It is positioned in LAA, doctor can be by making anchor actuating element 614 move to the second actuated position towards distal direction (referring to Figure 21) disposes the anchor portion 603 of medical treatment device 602.The 614 to the second actuated position of anchor actuating element The movement makes 632 distal movement of anchor pusher (as indicated as arrow 764), thus makes the anchoring of medical treatment device 602 Device part 603 is from retracted position distal movement to deployment or expanding location (Figure 38).Similarly, anchor portion 603 can Retracted position is back moved to from deployed position.

As shown in Figure 37 and as being described in detail in the previous embodiment, anchor portion 603 may include more A anchor ring 748 includes each first end 749 and the second end 751.The first end of each anchor ring 748 749 are attached to central part 752, and each the second end 751 is coupled together to form anchor central part.Work as anchor portion 603 in the retracted position when, the first end 749 and the second end 751 of each anchor ring 748 can be close to closers The distal portion of part 605.In addition, the second end 751 of anchor portion 603 can be close to central part 752.Moreover, when anchoring When device is in retracted position, the distal portion of the distal portion such as anchor ring 748 of anchor portion 603 is close to closer portion Divide 605 distal portion.By the arrangement, when closer part 605 is disposed, anchor portion 603 can be in retracted position It is independently moved between deployed position, thus provides physicians with and be selectively anchored on optimum position and direction in LAA The ability of closer part 605.

As described in Figure 38, anchor pusher 632 moves to the distal portion 758 of conduit 622, thus deployment medical treatment The anchor portion 603 of device 602 and anchor portion 603 is made to move to deployed position from retracted position.In deployed position, The first end 749 of each and the second end 751 in anchor ring 748 remain close to the distal end of closer part 605 The distal portion extension in portion and a part of separate closer part 605 of anchor ring 748.

Other embodiment description as previously explained, the part or anchor ring 748 of anchor portion 603 can lead to Central part 752 is crossed to outer rolling, is pushed via the mode of flip type arrangement other than anchor pusher 632.In this manner, anchor Determining device part 603 can move between the retracted position and deployed position such as described in corresponding Figure 37 and Figure 38, wherein The centering portions of anchor portion 603 can be moved or be shifted by the hole of central part 752.In one embodiment, anchor Part 603 can inward roll to retracted position and to outer rolling to deployed position.In another embodiment, anchor portion 603 can make anchor portion 603 by central part 752, and varus transfers to move to retracted position at least partly.In another reality It applies in example, anchor portion can be made anchor portion 603 turn up at least partly by central part 752 then move to deployment Position.

With reference to Figure 38, anchor portion 603 may include multiple anchor rings part, for example be six in this embodiment A anchor ring 748, and engagement member 766 is sized to and is configured to engage with the tissue in LAA.In the embodiment In, anchor ring 748 may include that the anchor of the most proximal end engagement member 766 of close given anchor ring 748 connects Contact portion point 768.Anchor contact portion 768 includes the outer surface of anchor ring 748, which can be against closer portion Divide 605 lower portion 770.The lower portion 770 of closer part 605 may include the strap of tissue growth component 762 Divide 772, which harder and more unyielding than the other parts of tissue growth component 762 (there can be smaller bullet Property).Band-like portions 772 can be sewed up to closer part 605 and/or are attached with adhesion.In addition, band-like portions 772 can be with It is substantially circular in shape to cover the downside of the distal portion of closer part 605.Band-like portions 772 can be for example by bio-compatible Property braided fabric or other arbitrary suitable materials formed, which will also promote tissue growth and provide than tissue growth component 762 other parts are harder and more non-yielding surface region.Furthermore, it is noted that although Figure 38 is depicted at them Closer part 605 in overall safety expanding location and anchor portion 603, but anchor portion can preload (or Slight limitation) to provide the power against the band-like portions 772 of closer part 605.In addition, the anchor and closer part 603 and 605 can be compressed in LAA to a certain extent so that anchor portion 603 and closer part 605 can carry For the radially outer power of the tissue against LAA.As a result, when anchor portion 603 is disposed, the anchor of anchor ring 748 Determine device contact portion 768 it is so structured that be biased against or push out against closer part 605 band-like portions 772 or under Side section 770 so that closer part 605 is pushed against tissue and the separate closer part in engagement member 766 and LAA 605 tissue engages.

In one embodiment, when anchor portion 603 is in deployed position (Figure 38), engagement member 766 can be with It is orientated to distal end and extends, and engagement member 766 can be orientated to remote when anchor portion 603 is in retracted position End extends (Figure 37).The variation in the direction of engagement member 766 in one embodiment can be due to overturning in anchor portion 603 And when turning up then being moved between retracted position and deployed position.For example, when anchor portion is moved from deployed position When to retracted position, the outer surface adjacent with engagement member of anchor ring 748 can be with inward roll or interior overturning so that appearance Face moves and becomes the inner surface of anchor ring 748.

In other embodiments, the position of engagement member 766 can be by changing as follows：Engagement member is set to be engaged in tissue It is moved between position and tissue unengaged position so that engagement member 766 is moved far from tissue surface, thus allows closer portion Points 605 setting and it is arranged again.Extension may be used in it, the extension can be limited to anchor ring 748 from Engagement member 766 nearby inwardly and the part that proximally extends, and is configured to when closer part 605 is maintained at deployed position It is pulled proximally when middle so that engagement member 766 moves to tissue unengaged position from tissue bonding station.In Figure 45-Figure 47 Other embodiment is depicted, these embodiments include the part as anchor portion, engagement member from medical treatment device The inside and extension proximally extended or extended element.

In another embodiment, anchor central part 774 may include the minor microstructure growth structure for being formed as sock structure Part 776.Previously embodiment shown in 9 described this sock structure referring to Fig.1.Sock structure is in anchor central part 774 Covering part is effectively provided at the close end of anchor 752, to promote tissue growth and assist preventing embolus from center It shifts in portion 752.Minor microstructure growth component 776 can pull on the close end of anchor central part 774 and pass through spring 778 maintain in the position, and spring is maintained in the recess (not shown) in anchor central part 774.Minor microstructure grows component 776 can by material similar with the tissue growth component 762 of closer part 605 such as polyurethane foamed material and/or EPTFE is formed.

In another embodiment, central part 752 may include that be longitudinally extended in the inner surface of central part 752 multiple lead To portion 780.Guide part 780 can be sized and be constructed in a manner of spaced apart so that when anchor central part 774 is being anchored When being moved between device retracted position and anchor deployed position, anchor ring 748 can be aligned relatively to each other and substantially Maintenance is close to each other or becomes tangling and entwine.Guide part 780 may include elongate tabs, Mei Ge in one embodiment It is longitudinally extended between the proximal openings and distal openings of central part.In another embodiment, extend along anchor ring 748 One or more lug (not shown) may be used as guide part to make when anchor ring 748 is shifted through central part 752 They are properly aligned with.In addition, in another embodiment, ring arrangement (not shown) may be used as guide part to allow anchor Ring 748 slides through ring arrangement, for being correctly aligned when movement is by central part 752.In another embodiment, Anchor ring 748 is individually configured to maintain the configuration of general plane or the configuration of substantially flat so that anchor ring 748 It is so structured that resisting the movement for the plane for deviateing general plane configuration.The resistance of movement to deviateing plane can also assist Being correctly aligned when movement is by central part 752 of anchor ring 748.

Such as previous in embodiment, anchor ring 748 may include coil line 782 or other components.Coil line 782 It may include the line wound with coil configuration around a part for anchor ring 748.The coil line 782 can provide in LAA Tissue other traction and the other surface region being in contact with the tissue in LAA is provided and promotes therein group Knit growth.In addition, coil line 782 is uncertain from being subjected between retracted configuration and guidewire lumen in anchor ring 748 Release mechanism is provided in the case of the anchor ring rupture of stress/strain.The coil line 782 can be included in coil line substantially The arbitrary rupture of 782 interior given anchor ring 748 itself.In including the embodiment of coil line 782, such as previously beg for Opinion, engagement member 766 can extend longer length for the appropriate gap beyond coil line 782.It is such as real previous It applies in example, engagement member 766 angularly extends and has blunt peak, to inhibit puncturing or piercing through to tissue substantially, to the greatest extent Manage they can be structured as when medical treatment device 602 dispose and proximally or towards LAA arteries and veins mouth movement or dragging with basic It prevents from effectively engaging with tissue from when its transfer.

It has been observed that medical treatment device 602 can couple via closer tether 628 and anchor tether 630 (referring to Figure 21 C) To steerable system 610 (Figure 21).Closer tether 628 and anchor tether 630 can pass through tether line connection (shown in dotted line) It is connected to the eyelet 730 of medical treatment device 602, tether line and 602 direct interconnection of medical treatment device.

May extend through sheath 604 as described previously and with reference to Figure 21 C tether system 608 illustrated, such as Figure 38 with Describe in Figure 38 A.As previously described, tether system 608 may include conduit 622, and conduit 622, which has, is configured to accommodating phase The center lumen 624 and peripheral lumens 626 of the anchor tether 630 and closer tether 628 answered, anchor tether 630 include Anchor pusher 632 and closer tether 628 include closer pusher 636.Anchor pusher 632 or anchor coil It is so structured that with enough axial compression strengths to push away anchor portion 603 (referring to Figure 37) from anchor retracted position It moves to anchor deployed position.Conduit 622 and closer pusher 636 it is so structured that provide axial strength or compressive strength with Medical treatment device 602 is forced through sheath 604.It disposes closer tether 628 when passing through conduit 622 or utilizes floating feature When, closer pusher 636 can provide axial strength or compressive strength.As previously illustrated, closer tether 628 and anchoring Each in device tether 630 may include tether line (as shown in phantom in Figure 38 and such as in Figure 38 A First Line 640 With the second line 642), which is connected directly to medical treatment device 602.Tether line can be structured as being conducive to medical treatment device 602 Pulling or retraction, and when for the retraction in tensioning in.For example, when closer part 605 is drawn to loader When in 754 (Figure 21) or in sheath 604, the position of medical treatment device 602 is maintained for the tether line of closer tether 628, and is added Device 754 or sheath 604 is carried to shift so that medical treatment device 602 can become being limited in sheath 604 relative to medical treatment device 602. Similarly, it is configured to anchor portion 603 being pulled to from anchor deployed position for the tether line of anchor tether 630 Anchor retracted position (Figure 37) in conduit 622, as described by arrow 784.

Briefly referring to Figure 39, show that the sectional view of an eyelet 730 of medical treatment device 602, tether can be connected to The eyelet.Such as description, tether (it can be closer tether 628 or anchor tether 630) can only join via tether line It is connected to medical treatment device.Tether line may include First Line 640 and the second line 642.In one embodiment, First Line 640 can be with It is stainless steel and the second line 642 can be Nitinol, however, it is possible to using other suitable biocompatibility materials for line Material.First Line 640 may be used as pulls wire and the second line 642 may be used as pin line.First Line 640 can be on middle section It folds, which limits the ring 728 for extending through eyelet 730.Second line 642 could be provided as extending through ring 728, which is depicted in below eyelet 730.First Line 640 then can tight beam to a certain extent, thus make One line 640 and the second line 642 are attached to medical treatment device 602.Releasing loose tether line from medical treatment device 602 can be by being implemented as follows： The second line 642 is such as pulled by arrow 732 first with indicating, until the second line by the ring 728 of First Line 640 retract, After this, First Line 640 can then be pulled from eyelet 730, and tether line is thus made to be detached with medical treatment device 602.Join above It is illustrated according to Figure 24 B and Figure 24 C by pulling the second line 642 to discharge medical treatment device in addition before pulling First Line 640 Explanation.

Referring now to Figure 40, show that medical treatment device 602, wherein conduit 622 (and sheath 604) are retracted with exposure and deployment The distal portions of closer tether 628 and anchor tether 630 be previously illustrated as floating feature and by manipulating floating Part 616 moves to the third actuated position of steerable system and is allowed (referring to Figure 21 and Figure 21 B).The floating feature can be used In enabling a physician to position of the assessment medical treatment device 602 in LAA and stability without applying torsional forces to medical treatment device 602 Or cross force and it will not potentially damage the tissue in LAA.For example, once anchor portion 603 is disposed, doctor Conduit 622 is withdrawn from medical treatment device 602, while keeping interconnecting via tether 628,630 and medical treatment device 602.Doctor is subsequent Medical treatment device is observed at the position that can occur when being released closer to device, and medical treatment device 602 can also be executed Promotion/pulling test, and pass through the tether 628,630 of imaging technique observation bending and the medical treatment device 602 slightly distorted.If Medical treatment device 602 is removed from LAA, and device easily can again be captured by as follows：By using previously described manipulation The function of system makes conduit 622 advance, and so that anchor portion 603 is retracted and sheath 604 is made to go forward in closer part 605 Into.The step of medical treatment device 602 is then able to follow previous explaination and be easily arranged again and be anchored.If doctor is executing Find that device 602 is correctly seated against in LAA after promotion/pulling test, then doctor is then able to release pine from medical treatment device 602 Tether line, as described herein like that.

As previously discussed, the frame section of medical treatment device 602 may include the tapered or variation on cross section to provide Desired structure feature and performance.For example, as seen in Figure 38, the width of anchor ring 748 can be along their length It spends tapered.It is noted that width is designated as " W " in the various attached drawings of this paper and since its size has radial direction component It is referred to as radial width.In the embodiment shown in Figure 38, anchor ring is in their radial inner end or second There is thicker width, and when they extend to bending part (that is, close to coil 768 in radial inner position at end 751 Locate the position terminated) such as relatively thin width is tapered at the second line coupling part 380 (Figure 11 A).In one embodiment, The tapered width that about 0.008 inch can be gradually become from about 0.015 inch of thickness.Extend past the connection of the second line Part, anchor ring 748 can gradually increase its width again at this location, and then curved in the whole of ring 748 Bent portions (that is, whole length attached by coil 768) change its width.In one example, whole bending parts are most Small width can be about 0.003 inch at the location roughly halfway up of the length of bending part.Anchor ring 748 with It afterwards can be cumulative to thicker width when extending from its most thin part back towards central part.In this embodiment, it is anchored The depth (that is, the size measured in the page) of device ring can remain constant.It is noted that depth is being included in each of this paper It is designated as " D " in kind attached drawing, and since its size on the substantially circumferentially direction around medical treatment device is also referred to as circumferential depth. In one embodiment, for example, depth can be about 0.017 inch.In other words, if anchor ring 748 is by material (example Such as Nitinol) plate cuts, then and plate of material can be 0.017 inch in this example embodiment.

In addition, for example, closer frame section 750 along a part of of its length can also include at least one tapered Portion.In one embodiment, width can be close on central part from being connected to along at least part of closer frame section End is tapered towards distal portion.Make possibility by the tapered portion of closer part 605 and the frame section of anchor portion 603 The foreseeable and unpredictalbe stress acted in the frame section minimizes, the rupture being thus limited in frame section Potential feasibility.Certainly, as known to persons of ordinary skill in the art, above-mentioned size can be by holding in frame section Row electrolytic brightening process and slightly change, such as in the acceptable margin of tolerance.The electropolishing of frame section further makes frame Potential rupture in tower section minimizes.

It is further noted that anchor ring 748 can be defined with desired depth-width ratio (that is, depth D is (in Figure 40 The page in measure) than width W (with the substantially transverse measurement of depth).In one embodiment, anchor ring 748 can be with Including being at least about 2 with depth-width ratio:1 part.In another embodiment, anchor ring 748 can wrap It is between about 1.1 to include with depth-width ratio:1 and about 5.7:Part between 1.But in other embodiments, It is between about 1 that anchor ring 748, which may include with depth-width ratio,:1 and about 12:Part between 1.In addition, Along the length of closer frame section 750 a part, can for depth-height ratio of closer frame section 750 Think at least about 2:1, but may include between about 1 along the length of closer frame section 750:1 and about 4:1 it Between range.In one embodiment, the depth-width ratio of closer frame section 750 is used for along closer frame section 750 Length on can be between 1:1 and 12:In 1 range.

In another embodiment, medical treatment device 602 may include different size selection, for example, small size, middle size and Large scale.The size selection can be mainly by means of in complete extended mode and the anchor that is attached on central part 752 Part 603 measures.For example, each anchor frame section of anchor portion 603 may include length and height, length The distance of the distal end from the close end of central part to anchor ring 748, and height be such as anchor ring with 605 touching position of closer part between anchor ring, relative to length and the lateral distance vertical with length.It is right In different size selections, the height of anchor portion 603 may include for example being respectively used to small size, middle size and large scale 21mm, 28mm and 35mm.The length of anchor portion 603 for different size selections may include being respectively used to small ruler Very little, middle size and large-sized 18mm, 22mm and 25mm.Certainly, these size selections can change and the present invention and unlimited In the size selection.

Referring now to Figure 41 and Figure 41 A, the conduit 802 for being configured to be pivoted at the distal portions 804 of conduit 802 is shown Distal portions 804.The conduit 802 can be the conduit described in the embodiment above, and can be sheath described above Set.Conduit 802 can limit center lumen 806 and multiple peripheral lumens 808, such as four peripheral lumens, each along conduit 802 longitudinal length extends.In addition, in the distal portions 804 of conduit 802, conduit 802 can be defined in conduit 802 Slit 810 or recess therein are extended transversely through between outer surface and inner surface.The slit 810 can be limited to multiple columns In, such as along four columns of the distal portions 804 of conduit 802 slit 810 staggered configuration opposite with two groups so that slit 810 adjacent pillars are interlocked relative to each other.Slit 810 can limit slit configuration, wider at middle part and in the opposite of slit End is narrower.May be used a variety of slot configurations, for example, crescent, v-shaped, spiral shape or other arbitrary suitable shapes it is narrow Slot.By the arrangement, slit 810 be conducive to relax conduit 802 distal portions 804 transverse strength to allow wherein bigger Flexibility, while the axial strength of the distal portions 804 of basic maintenance conduit 802.

In addition, conduit 802 may include the line 812 or other structures structure for the peripheral lumens 808 for extending through conduit 802 Part.The line 812 can be fixed to the distal portion 814 of conduit 802 for example, by line 812 is fixed to plate 816.Plate 816 is also May include opening 818 corresponding with peripheral lumens 808, the end of line 812 can be fixed to the opening 818.Plate 816 can be with The tension that is applied on plate by means of line 812 includes such as binder by other independent devices by is fixed to The distal portion 814 of conduit 802.The center lumen 806 of conduit 802 can be used for conveying medical treatment device for permanent or short-term Arrangement, or for other arbitrary suitable purposes, for example, be introduced into substance, from vascular retracting device or unexpected substance, Channel for another conduit is provided or other the arbitrary suitable purposes for pivoting conduit may be used.

With reference to Figure 42 and Figure 42 A, conduit 802 could be attached to pivot manoeuvre system 830.Steerable system 830 may include The pivot manoeuvre component 832 being arranged between distal end actuating element 834 and proximal end actuating element 836, such as universal joint or arbitrary Other suitable pivot members.Each in distal end actuating element 834 and proximal end actuating element 836 can define axis respectively To extending through their corresponding parts and be configured to the first hole 838 being axially aligned with respect to each other and the second hole 840.It leads Pipe 802 can extend axially through manoeuvre portion 830, i.e. the first hole 838 of distal end actuating element 834, and be manipulated with proximal end Part 836 at fixed relationship extends through at least part in the second hole 840 of proximal end actuating element 836.In addition, in distal end Between actuating element 834 and proximal end actuating element 836, steerable system 830 may include setting in the pivot manoeuvre component 832 or The deflection component 842 being disposed adjacent.

As shown in Figure 42 A and Figure 43, deflection component 842 may include tubular configuration, have laterally across tubulose structure Multiple channels 844 spaced apart that the periphery of type limits.Deflection component 842 can be elastic component, be sized to and be configured to It is bent or distorts when pivot manoeuvre component 832 manually pivots.Deflection component 842 may include extending through deflection component 842 central opening 846, and peripheral openings 848 along deflection component 842 periphery extend and with the axis of central opening 846 Line is corresponding or is basically parallel to the extension of the axis of central opening 846.The peripheral openings 848 can be sized to and be configured to prop up Hold line 812 and guide line 812 pass through, and central opening 846 can be sized to and be configured to setting extending through On conduit 802 therein.

With reference to Figure 42 A, conduit 802 can define open in distal end actuating element 834 at the proximal part of conduit 802 Mouth 850, line 812 may extend through the opening 850.In addition, defining the first pipe fitting 852 of the lumen passed through from opening 850 extend outward and proximally and extend through distal end actuating element 834, and are constructed so that line 812 extends through the The lumen of one pipe fitting 852.For example, four lines 812 may extend through conduit 802,850 and pass through correspondence by four openings The first pipe fitting 852, single line 812 extends through an opening 850 and corresponding first pipe fitting 852.Opening 850 can with Another opening is limited at opposite position in conduit 802 so that each adjacent opening can be with another opening away from about 90 Degree is radially arranged.Certainly, if equipped with the more or fewer lines of examples that are open than above four lines and four and corresponding Opening, then the opening can be equally spaced around conduit with other angular frequencies.

In addition, as previously illustrated, when being compared with the spacing of the line 812 in conduit 802, line 812 can connect up For from opening 850 outward and proximally extend through the first pipe fitting 852 to bigger spaced relationship.The continuation of line 812 proximally extends By the peripheral openings 848 (Figure 43) of deflection component 842 and pass through proximal end actuating element 836.The actuating element 836 in proximal end Interior, every line 812 may extend through at least one second pipe fitting 854.

With reference to Figure 42 A and Figure 44, proximal end actuating element 836 can also include wire bonding component 856.Wire bonding component 856 May include rotatable knob 858, skewed surface (herein referred as inclined-plane 860), multiple spheres 862 and inner member 864.Inclined-plane 860 It can be the inner surface of knob 858 and may include being defined in pawl surface therein (detent surface) 866, the tug Pawl surface has multiple inclined, recess the parts radially extended in inclined-plane 860, these parts are sized to and are configured to It is corresponding with sphere 862 and with line 812 is close or the relationship of clamping makes sphere 862 move.In addition, inner member 864 can be with The recess portion 868 extended through including line 812.By the arrangement, pawl surface 866 is corresponding with sphere 862 so that works as knob When 858 rotation, pawl surface 866 rolls on sphere 862 and is configured to that line is clamped against inner member 864.In this manner, line 812 can be placed in in the fixed relationship of proximal end actuating element 836.When knob 858 is rotated to disengaged position, line 812 can be with It fluffs in the second pipe fitting 854 and is only fixed at the distal portions 804 of conduit 802.In addition, as previously illustrated, line 812 Wiring is to extend through steerable system 830 in spaced relation and in particular by deflection component 842.Have with line 812 The case where spacing similar with the spacing of the line 812 in conduit 802, is compared, the increased radially spaced pass of line 812 System is advantageously used for the broader stroke of line 812 to pivot the distal portions 804 of conduit 802.

More specifically, for example, referring to Figure 41 and Figure 42 A, if distal end actuating element 834 is via pivot manoeuvre component 832 It pivoting downwards, then the 812a that reaches the standard grade (that is, the line of "upper" line is portrayed as in Figure 42 A) will movement be tensioning in deflection component 842, and Offline 812b will have smaller or no tension.Since line 812 is fixed in proximal end actuating element 836, distal end actuating element 834 This move downward and pull on or pivot in the difference for reaching the standard grade the tension between 812a and offline 812b and (still consider Figure 42 A Direction) distal portions 804 of conduit 802 are in upward configuration.

Similarly, moving upwards for distal end actuating element 834 will be set due to the flexibility of deflection component 842 by offline 812 In tension or offline 812b is pulled, the distal portions 804 of conduit 802 is thus made to pivot downwards.Similarly, it is routed through flexure The line 812c and 812d (being only shown in FIG. 44) of the side of component 842 are beneficial to make the remote of conduit 802 by similar arrangement End part 804 laterally pivots.In this manner, line 812 is fixed in proximal end actuating element 836 and makes line 812 at interval It is advantageously used for making the distal portions 804 of conduit 802 effectively to pivot required stroke by deflection component 842, the trip is Along with distal end actuating element 834 via the opposite direction of 832 pivoting direction of pivot manoeuvre component.Note that although above right The description of pivot manoeuvre system 830 has been provided for conduit, such as the above conduit for conveying medical treatment device illustrated, But pivot manoeuvre system can be also used for the sheath for the medical device delivery system previously illustrated, or for pivoting conduit institute Desired any appropriate purpose.

Referring now to Figure 45, medical treatment device 900 according to another embodiment of the present invention is shown.It is noted that cut Face shows the only a part of medical treatment device 900.Medical treatment device 900 includes closer part 902 and anchor portion 904, It is similar to various embodiments previously described herein.Closer part 902 may include tissue growth component 908 and multiple occlusions Device frame section 906.Anchor portion 904 may include the multiple anchor frame sections for having engagement member 912 or lug 910.Engagement member 912 can be similar to those of being described with reference to other embodiment provided herein.With it is previously described Embodiment is the same, and closer part 902 and frame part 904 discretely and can be disposed individually.

Extended element 914 could be attached to the distal portion 916 of each anchor frame section 910 and from engagement member 912 nearby inwardly and proximally extend.For example, in one embodiment, extended element 914 may include being connected to and frame section The silk thread or line on eyelet 918 (or other coupling members) that section 910 is connected.Extended element 914 is it is so structured that for example from anchor The distal portion 916 for determining device section 910 proximally extends and extends through central section 920, which will be various Closer frame section 906 and anchor frame section 910 are coupled together.When in use, extended element 914 can be proximally Displacement with being arranged or capture again for device 900 of anchor frame section 910 of retracting again.In one embodiment, anchor Frame section 910 when extended element 914 proximally shifts it is so structured that primarily radially upcountry shift.In another embodiment In, anchor frame section 910 it is so structured that be rolled in conduit or the other component of conveying device in, and it is described herein Other embodiment is similar.

When medical treatment device 900 is satisfactorily deployed in LAA, extended element can be separated with anchor frame section 910. For example, the eyelet 918 that extended element 914 can be connected with them is separated and is retracted from device 900.In another embodiment, Extended element 914 can maintain with eyelet 918 be connected but such as cut or cut off at the proximal end face of medical treatment device 900 or Release.Although extended element 918 as in tensioning in structural elements so that anchor frame section 910 retract, it Can also be configured as in certain embodiments in compression in structural elements to be pushed against anchor frame section 910.In the case where extended element 914 is also used as compression element, they can be pivotably coupled to anchor frame section 910。

With reference to Figure 46, medical treatment device 930 according to another embodiment is shown.Medical treatment device 930 includes anchor portion With closer part, wherein anchor portion includes that multiple anchor frame sections 932 (shown for convenience's sake by only one Go out), closer part has the tissue growth component 934 being directly connected with anchor frame section 932.Engagement member 936 can To be formed on distal end and the radially outer part of anchor frame section 932.Extended element 938 can with with reference to Figure 45 The similar mode of those of description is connected in anchor frame section 932 and function is essentially identical.In this embodiment, work as doctor When treatment device 930 is disposed, if doctor it is expected the more preferable position being set to again in LAA, extension can be proximally pulled Component 938 is so that engagement member 938 moves to tissue unengaged position from tissue bonding station.Doctor then can be by closer Part is being arranged to preferred position and is then releasing loose extended element 938 so that anchor frame section 932 can be from extension And engagement member 936 is made to move to tissue bonding station.The process can repeat to be pleased with the position of medical treatment device 930 until doctor The release of medical treatment device 930 is set and then carries out, it is similar to what is described in the previous embodiment.

With reference to Figure 47, medical treatment device 950 according to another embodiment is shown.Medical treatment device 950 may include closer Part and anchor portion.Anchor portion may include with the engagement extended from the radially distant end part of frame section 952 Multiple anchor frame sections 952 of component 936.Closer part may include being connected to multiple anchor frame sections 952 Proximal end face on tissue growth component 934.In this embodiment, medical treatment device 950 and the base for showing and describing with reference to Figure 46 This is identical, in addition to instead of individual extended element (for example, extended element 938 shown in Figure 46), anchor frame section 952 include ring part 954 (its have from 952 extension that is adjacent and inside and proximally extending of engagement member), this The individual extended element of embodiment shown in ring part 954 and Figure 45 and Figure 46 is similarly acted or is worked.

Although the present invention is easy to the form of different modifications and replacement, specific embodiment herein, which has been used as, to be shown Example is shown in the accompanying drawings and has been described in detail.It is understood, however, that the present invention be not intended to be limited to it is disclosed Concrete form.In fact, the present invention includes falling the spirit and model of the present invention limited in the attached claims such as below All modifications, equivalent and replacement in enclosing.

Claims

1. a kind of medical treatment device for correcting the left auricle of heart (LAA) of heart, the medical treatment device include：

Closer part, the closer part are attached to central part；And

Anchor portion, the anchor portion are operably coupled to the closer part, the anchor portion construction For by making the anchor portion, relative to the closer part, varus transfers to move to retracted position at least partly, and And it is configured to move to deployment by making the anchor portion turn up at least partly relative to the closer part Position,

Wherein, the anchor portion includes multiple anchor sections, and each anchor section includes first end and second end Portion and the centering portions between the first end and the second end, the first end of each anchor section Portion is operably coupled to the closer part, the second end of each anchor section be configured to proximal movement with Make the anchor portion interior overturning at least partly, and the second end is configured to distal movement so that the anchor Part outer overturning at least partly.

2. medical treatment device as described in claim 1, wherein the anchor portion includes tissue engagement surface, when in institute The tissue engagement surface is the outer surface of the anchor portion when stating in deployed position, and when in the retracted position The tissue engagement surface is the inner surface of the anchor portion when middle.

3. medical treatment device as described in claim 1 further includes engagement member, the engagement member is orientated and is configured to work as institute State proximally extend from the anchor portion when anchor portion is in the deployed position and with the tissue of left auricle of heart It engages.

4. medical treatment device as described in claim 1 further includes engagement member, the engagement member is orientated and is configured to work as institute It states when anchor portion is in the deployed position and proximally extends from the anchor portion, and be orientated and be configured to Extend from the anchor portion to distal end when the anchor portion is in the retracted position.

5. medical treatment device as described in claim 1, wherein the closer part includes the group for having the inner surface and the outer surface Growth component is knitted, the tissue growth component is configured to be led to tissue growth.

6. medical treatment device as claimed in claim 5, wherein the anchor portion is configured to be biased against the tissue growth The inner surface of component so that the outer surface of the tissue growth component is in contact with the tissue in left auricle of heart.

7. medical treatment device as claimed in claim 5 further includes engagement member, the engagement member is orientated and is configured to remote It is engaged with the tissue of left auricle of heart at position from the tissue growth component.

8. medical treatment device as described in claim 1 further includes guide part, the guide part is configured to work as the anchor portion The anchor section of the anchor portion is guided and is aligned when being shifted between the retracted position and the deployed position.

9. medical treatment device as described in claim 1, wherein the multiple anchor section includes around the multiple anchor portion The line that a part for section is wound with coil configuration.

10. medical treatment device as described in claim 1 further includes the multiple engagement members being connected with the anchor portion, often A engagement member has wave crest configuration.

11. medical treatment device as described in claim 1, wherein the closer part is configured at the anchor portion Closer deployable state is moved to when in the retracted position.